Pfizer

Pt states got Covid vaccine today ay 730am, shortly after started feeling dizzy and scratchy throat. She was sent to the ED. ED treated as follows: Solu-Medrol, Benadryl and Pepcid given intravenously. Patient was monitored in the emergency department for improvement of symptoms. Her throat fullness and pruritus resolved. She feels well and wishes to be discharged home. Pepcid, Benadryl and prednisone prescribed for treatment of any recurrence of allergic reaction symptoms that might occur when she is discharged. She will return to the hospital should symptoms worsen. She returned to the ED the next day and these are notes from that visit: 26-year-old female, past medical history significant for asthma and irritable bowel syndrome presents to the emergency department with complaint of allergic reaction. Patient states she took the Covid vaccine yesterday and with 8 minutes developed tightening in her throat and rash. She presented to the emergency department yesterday and was treated with Solumedrol, Pepcid and Benadryl which relieved her symptoms. She was discharged home with Pepcid Benadryl and prednisone however she has not taken the prednisone because she does not like how it makes her feel. She states this morning she developed tightness in her throat, nausea and felt as if she were going to pass out. She states when her symptoms began she took Pepcid and Benadryl but did not take any prednisone. Upon arrival she is very anxious, talking in complete sentences, no drooling noted 1241: EKG sinus tachycardia rate 111, PR 0.14, QRS 0.08, QT 0.30, no acute changes. Initial read by Dr. at 1243   1 L normal saline IV, Solu-Medrol 125 mg IV, Benadryl 25 mg IV and Ativan 1 mg IV for relief of symptoms. Patient verbalized that she felt her symptoms were combination of allergies uric reaction and anxiety. I have encouraged her to take the prescriptions as directed at her ER visit yesterday. Procedures   MDM   Return the emergency department new symptoms or concerns worsening of current condition.1241: EKG sinus tachycardia rate 111, PR 0.14, QRS 0.08, QT 0.30, no acute changes. Initial read by Dr. at 1243   1 L normal saline IV, Solu-Medrol 125 mg IV, Benadryl 25 mg IV and Ativan 1 mg IV for relief of symptoms. Patient verbalized that she felt her symptoms were combination of allergies uric reaction and anxiety. I have encouraged her to take the prescriptions as directed at her ER visit yesterday.  

fever and headache 5 hours after taking shot. Fever and headache lasted roughly 30 hours. Three days after taking shot started to itch real bad and have hive like bumps. Currently still have itching bumps 4 days after shot

By evening, arm around the injection site grew increasingly painful, to the point where it hurt to move or touch (not unbearable but more soreness than any other injection I've ever received). Over night contracted a fever, by the time I was able to get up to measure it (around 3:45 AM) it was 99.5 degrees, and broke by 5 AM. Had fever dreams prior to waking around 3 AM, and had chills for the remainder of the night. Felt achy and a little unsteady for the rest of the day but was fully recovered by 12/31

On 12/24 at around 10 PM, circulation to my 4th left digit significantly decreased after being outside of my car for around 15 minutes during a temperature of about 50 degrees. I realized when sharp pain was felt at the digit. After about 5 minutes the digit felt numb. I got in my car, turned on the heater, and massaged my finger. Sharp pain was felt again as circulation returned to the digit. The event last approximately 10 minutes from the moment I realized the finger was pale until color returned. This occurred again on 12/27 at around 2 PM as I walked from my car into a store at a temperature of about 40 degrees. This time, discoloration occurred bilaterally on my left 3rd, 4th, and 5th digits and my right 2nd, 3rd, 4th, and 5th digits. The event lasted more than 15 minutes with constant massaging. This has occurred two more times since then, both times occurring bilaterally with minimal exposure to cold.

Systemic pruritis (itching) all over body; COVID test type: Nasal Swab and Rapid Antigen and were both positive; COVID test type: Nasal Swab and Rapid Antigen and were both positive; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient started to receive BNT162B2 (lot number: EJ1685), intramuscular on 17Dec2020 16:30 at single dose in the left arm for COVID-19 immunization. Medical history included hypothyroidism from an unknown date. The patient was not pregnant at the time of vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID) and spironolactone. The patient previously took cefprozil (CEFZIL) and tapazole and both experienced allergies. The patient experienced systemic pruritis (itching) all over body on 22Dec2020 10:00. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient has been tested for COVID-19. On 22Dec2020, the patient took COVID test type: Nasal Swab and Rapid Antigen and were both positive. No treatment received for the event "Systemic pruritis (itching) all over body". The outcome of the event "Systemic pruritis (itching) all over body" was not recovered. The outcome of the other events was unknown.; Sender's Comments: BNT162b2 provides protection against COVID-19 after 7 days from the second dose. This case does not match this codition

I am 20 weeks, 4 days. I am due may 20th, 2021. I got the vaccine at work and felt fine. I was getting in my pajamas for the night and my husband noticed a weird rash on my body. It did not itch or hurt. I took a shower and a Tylenol and went to bed. I woke up at 5am the next morning and it was completely gone.

I had a very sore arm; lightheadedness/dizziness; back ached; felt like I had the flu - body aches; felt like I had the flu - body aches; shivering/chills; nausea; fatigue; This is a spontaneous report from a non-contactable nurse (patient). A 26-year-old female patient received bnt162b2 (lot number: EH9899, brand=Pfizer-BioNTech), via an unspecified route of administration, at arm left, first dose on 16Dec2020 10:00, at single dose for COVID-19 immunization. No relevant medical history. No allergies to medications, food, or other products. Concomitant medication included ethinylestradiol, norgestimate (TRI-SPRINTEC), spironolactone (SPIRONOLACTONE) both from an unspecified date for unspecified indication. The patient is not pregnant at the time of vaccination. Age at vaccination was 26. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. About 12 hours after the COVID vaccine (also reported as from 16Dec2020 21:00), the patient suddenly felt like had the flu-body aches, shivering, nausea, fatigue, chills, but no fever. She went to bed and woke up the next morning (17Dec2020) feeling fine, except she had a very sore arm and was fatigued. Also had some lightheadedness/dizziness that second day and her back ached. No treatment was received for the adverse event. The events were reported as non-serious. The outcome of the events was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.

-Injection site pain 12 hrs later, pain severe 7/10, arm painful to light touch 18 hrs later: -Flushing/hot flashes throughout the day -Persistent headache lasting 24hrs -General fatigue All symptoms subsided after 48 hrs

Patient began having flushing and hives, chest tightness, shortness of breath, voice changes - began ~20 minutes after occurrence. Given IV benadryl 50 mg immediately - noted some improvement of symptoms. Symptoms persisted, arrived in ER, given IM epi 0.3 mg, PO prednisone 50 mg, and PO pepcid 20 mg approximately 1 hour after administration

Went to the ER on the 31st, my face swelled and chest was covered in hives. Lips swelled. I would get nauseated and I felt like there was acid in my stomach. I also had a headache. I have been taking Zyrtec, Benadryl as needed.

on 7th day post vaccination, I had left upper arm swelling, rash, and pain where there had previously been none. Freckles on that upper arm scabbed over and peeled. This event lasted less than 2 hours. No medications taken, no medical care received. No further reaction since then.

12/23/20- mild arm soreness 12/24-12/25- (worse) very tender arm at injection site 12/24-12/25- extreme fatigue (literally no energy) 12/24- for a couple to several days- restless sleep/insomnia 12/24- (off an on for a few days) headache and runny nose All symptoms resolved within a week. Only took Tylenol or ibuprofen for headache/arm soreness. Massaged arm to help soreness and applied a cold compress.

Initial reaction (within 5 min) was minor chest tightening and at the 15 min mark I started to get hives, I let the nurses know of my reaction and they provided me with Benadryl, I then stayed for about an hour after. It has now been about a week, hives still present and starting to present as a rash.

Headache Body ache Fatigue Painful soreness at the injection site Swollen lymph nodes on arm of injection site - painful sore ness Chest pain

Patient reported expanded red petechia (red spots) on bilateral lower extremities including feet and knee area. Patient got CBC and went to PCP. CBC was normal except platelets low-normal 150,000. No itching, swelling, etc. This occurred about 9 days after vaccination. Improved gradually and mostly normalized 3 weeks out when receiving 2nd dose of vaccine. No other symptoms reported besides sore arm for 2 days.

rash on body; The patient reported she became pregnant while taking bnt162b2/Gestation Period at Exposure was 20 weeks; The patient reported she became pregnant while taking bnt162b2/Gestation Period at Exposure was 20 weeks; The patient reported she became pregnant while taking bnt162b2/Gestation Period at Exposure was 20 weeks; This is a spontaneous report from a contactable other healthcare professional (patient). A 26-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration in the left arm on 04Jan2021 14:30 at a single dose for COVID-19 immunization. The patient's medical history included allergies to sulfa drug. Concomitant medication included minerals nos, vitamins nos (PRENATAL VITAMINS). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took cipro [ciprofloxacin] and experienced allergy to cipro. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient's husband noticed a rash on the patient's body when the patient was getting into pajamas for bed. She took a shower and paracetamol (TYLENOL) and went to bed. She woke up in the morning and rash was gone. The mother reported she became pregnant while taking bnt162b2. Last menstrual period date was 13Aug2020. The mother was 20 weeks pregnant at the onset of the event. The mother was due to deliver on 20May2021. Outcome of the rash was recovered. The events were considered non-serious by the reporter.

Hives, started 24 hours after vaccine administration, present for about 1 week after vaccine dose, improved with antihistamine therapy. no lip/tongue swelling, shortness of breath, vomiting, syncope, hypotension

Arm pain at injection site; fever of 101; chills; severe body aches; mild headache; nausea; This is a spontaneous report from a contactable nurse. A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot numbe: EK5730), via an unspecified route of administration on the left arm on 31Dec2020 10:00 at single dose for COVID-19 immunisation. Medical history included anxiety, and covid prior vaccination: Yes. Concomitant medication included sertraline hydrochloride (ZOLOFT). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date. The patient experienced arm pain at injection site, fever of 101, chills, severe body aches, mild headache, nausea on 01Jan2021. The patient received no treatment. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

Right side of face started to swell with blotching. It then went away . Injection site is raised , swelling and itching along with bruising . Hives began again on my arms and injection site .

Allergic reaction to covid shot on 11/8 Around 11:20am I got the shot by 11:25am i was dizzy my throat started to hurt, and my chest started to hurt. I was a shot of EpiPen and benadryl before I was wheeled down to the ED and was given dexAMETHasone at 1:02pm and ibuprofen at 2:36pm cause my head started to hurt more . Arm is till hurting at the injection site

Headache and fatigue 2-3 post injection, arm soreness approximately 8 hours post injection. Poor sleep night of injection, woke up at 0630 with significant muscle aching, allodynia, and headache

Patient received vaccine at 7:31 am. At 7:37 am patient reported burning at injection site/right arm. Minutes later started complaining of burning in her throat. Bloor pressure 138/80 Pulse 142 Oxygen 100 Temperature 98.2. Lungs sounded clear. No wheezes. At 7:47, patient reports tightness in throat has subsided but feels swollen, tightness in chest. Is still able to drink water. Blood pressure 140/90 HR 120 Oxygen 100. Called 911. Patient had many questions about receiving Epi Pen. Denies heart conditions, reports has a history increased heart rate. At 7:49 am Epi pen given left lateral thigh. BP 142/78.100% Oxygen, Pulse 129. EMS arrived few minutes after. Blood noted on left lateral thigh at Epi injection site. 2x2 applied with pressure. Report off to EMS.

About 30 minutes after vaccination, patient notiched itchiness which progressed to hives on her bilateral arms and face. Around two hours after the vaccination while on the phone with our covid vaccine team, she developed tachycardia and shortness of breath. She called EMS and was evaluated at home at which time her symptoms were improving. They advised that she was not having anaphylaxis and could stay at home. She went to urgent care and received PO Benadryl.

1.5 hrs after injection, patient noted redness, mild induration, warmth, tenderness; defined 6cm x 4cm affected area. No change in 3 days since injection; she presented to Health for assessment; site is defined, mild erythema, mild induration, tender. Recommended to apply cold pack, take ibuprofen as anti inflammatory, consult PCP and monitor, and return in 2 days 1/13/21 for update. Advised that PCP may possibly want to prescribe antibiotics if no improvement/resolution (possible cellulitis? does not appear as such to date)..

Approximately four hours after receiving the COVID-19 vaccine I felt injection site pain. During the night I began experiencing muscle aches, chills, headache, and just an overall feeling of pain/flu like symptoms. This lasted for approximately 24 hours.

I am currently 20 weeks pregnant. y left arm was really sore after the injection. I had pain under my left armpit with fever and chills and felt fatigued. My symptoms lasted two days. I slept a lot during the day and day after the injection . I did not get care from a hospital or doctor.

Had me wait for 15 minutes after vaccine and started having a redness in neck and was really itchy; whole body big time itchy. My chest - shortness of breath. Gave me a shot of benydryl - 25 mg in my right arm and I went home and itching still didn't go away and I took pill of benydryl. Chills next day; super cold; headache; tired - and I couldn't think straight. Nothing was registering in my head with training at work - felt slow. Went home from took more benydryl. Next morning - pins and needles in back of my head. Went to urgent care (Riverside Urgent Care) and they gave me gave me Vexamethasone - shot it up in my butt and every symptom went away after that shot and I was okay after that.Itching went away after that. Felt weak for about a week afterwards. Went and had second shot yesterday 1/10/2021. They gave me medication with vaccine so I wouldn't get reaction this time. Gave me liquid 25 benydryl beforehand and had me wait 15 mintues and after 15 min they gave me the second dose of vaccine after the injection and they had me wait for 30 minutes. Right away I started getting itchy and they gave me pill form( 2 pills) of Vexamethsone and itching slowly stopped and they sent me home after an hour. Itching slowly went away - later that day. And today I'm okay.

chills, hot flashes, swollen injection site, painful injection site/entire Left arm, body aches, fatigue

Heat and redness around injection site - occurred one day after injection and continues to be present

Vaccine Dose 1 12/17/2020: I received the vaccine and within 5 minutes I experienced dizziness, sweating and was flushed. After 15 minutes the dizziness did not go away and my vitals were checked. My BP was elevated 136/106 and HR 105, I was taken to the ED after repeated BP readings continued to show increased diastolic pressure. I was observed in ED for a period of almost 6 hours. Within an 1.5 hours after receiving vaccine, I had right neck stiffness, headache, and some weakness to the right side as well along with the dizziness and high BP. I received a 1L bolus of NS, 2 doses of antivert, Toradol, Zofran and Lidocaine patches. 24 hours after receiving vaccines, I was having pain at the insertion site, headache, neck stiffness and occasional dizziness. After 36 hours my symptoms subsided and I felt back to baseline. Vaccine Dose 2 01/07/2020: I received my second dose of the COVID vaccine and within the first 15 minutes I experienced dizziness, nausea, flashing spots in vision, right sided weakness, increased BP & HR, redness and sweating. After 30 minutes the symptoms did not subsided and I was taken to the ED. An hour after receiving the vaccine, I had right sided weakness to arm and legs with no numbness, dizziness, R. sided neck stiffness, right sided headache, nausea and flashing spots. I received Ativan, Reglan, Tylenol, Toradol and Benadryl in the ED. I was in ED for 3.5 hours after vaccines was administered and was able to ambulate to the car independently. 16 hours after receiving vaccine, I had muscle weakness to bilateral lower extremities and was unable to ambulate independently along with dizziness, headache, arm soreness, cough, congestion, neck stiffness and fatigue. 36 hours after vaccine I regained movement to bilateral lower extremities however still was experiencing fatigue, occasional dizziness, intermittent neck stiffness and headache, body aches and some shakiness to lower extremities. 55 hours after receiving vaccine I was still fatigued and experiencing intermittent headache and neck stiffness. 72 hours after vaccine I was still fatigued and having occasional headaches but feeling much much better from initial reaction. 96 hours after receiving vaccine I experienced occasional headache, woke up with neck stiffness and was finally able to drive a car without any dizziness or nausea. 144 hours after vaccine I am not completely back to baseline still fatigued with occasional neck stiffness and headache but able to go back to work.

?Pfizer-BioNTech COVID-19 Vaccine EUA? Symptoms experienced: Lightheaded, Shortness of breath with hyperventilation. She was laying on the floor and appeared shaky with red blotching on face and neck. Actions taken: Medical Response called. Anaphylaxis Medication given epinephrine (adult) IM outer thigh. Patient was placed on stretcher and taken to ER. Pt also received diphenhydramine and famotidine in ER

Within fifteen minutes of the vaccine became itchy all over and pharmacy administered Benadryl. This morning she developed a temp of 99.4, shaking all over, chest hurts, cough and aching

Pfizer-BioNTech COVID-19 Vaccine EUA Symptoms experienced: Lightheaded, shortness of breath with hyperventilation. She was laying on the floor and appeared shaky with red blotching on face and neck. Actions taken: Medical Response called. Anaphylaxis Medication given epinephrine (adult) IM outer thigh. Patient was placed on stretcher and taken to ER. Patient also received diphenhydramine and famotidine in ER.

Pfizer-BioNTech COVID-19 Vaccine Symptoms experienced: Lightheaded, shortness of breath with hyperventilation. She was laying on the floor and appeared shaky with red blotching on face and neck. Actions taken: Medical Response called. Anaphylaxis Medication given epinephrine (adult) IM outer thigh. Patient was placed on stretcher and taken to ER. Diphenhydramine and famotidine given in ER

Started to feel itchy on right neck area approximately 5:25 5 minutes after receiving . Denies problems with breathing. No respiratory distress. Lungs ctabl, no stridor, no jvd. RR 12 unlabored even. CV Blood pressure 143/93 97 99% on RA after deep breaths BP 125/88 96b 99% O2 sat. Consulted with Medical Director called 911 for evaluation. Paramedics called and evaluated employee. They recommended on site observation and Benadryl. One 3-4 mm raised blanched wheal at right neck observed, "itchy" scratched x1 when itched. "Tried to not scratch" Denies any respiratory difficulty. Benadryl 25 mg given 6:21 PM, 6:52 employee doing well 98 % 85 heart rate 132/88 16 referral provided for if needed follow up care.

Low grade temperature; myalgias; fatigue; neck pain; injection site tenderness; This is a spontaneous report from a contactable physician (patient herself). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) intramuscular (right arm), on 05Jan2021 at 16:00, at a single dose, for COVID-19 immunization. The patient has no relevant medical history and has no known allergies. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular (left arm), on 17Dec2020, for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 05Jan2021 at 21:00, the patient experienced low-grade temperature, myalgias, fatigue, neck pain, and injection site tenderness. The patient did not receive treatment for the events. Outcome of the events was not recovered. Information on the lot/batch number has been requested.

Neck and facial hives with swelling. Face was red and hot to tough. Benadryl taken-symptoms resolved by am

I did okay with the first dose only experienced site pain and fatigue. This second dose has not been pleasant: I am experiencing injection site pain, headaches, body aches, chills, and back pain.

Per pt, sx onset began at 1520 with pruritus/hives of the scalp. She was in the post vaccine observation area at this time. At 1530, EE returned to vaccination room to alert staff of her reaction. Upon hearing her new onset cough, an assessment was performed immediately. Reported tingling and swelling of her lips, cough, minor difficulty breathing with mask on, facial flushing and feeling hot, and severe pruritus, especially on the scalp. 50 mg IM Benadryl administered and was taken to ED via wheelchair which is 7 minutes away. Epi Pen administered in ED and admitted overnight for observation d/t irregular HR and ST depression on monitor.

Redness, tender and warm to touch at injection site, redness streaking down to inner side of right arm. Noticed redness and tenderness on day 2. Day 3 has slightly more redness surrounding injection site, 2 inch in diameter circular redness, and increased redness down arm. On day 3, the red streak is approximately 1 inch in width and 3 inches in length.

Patient developed angioedema of her eyelids after COVID-19 vaccination. She received her Covid vaccine on 1/10/2021 at 11:30 AM. She received the Pfizer vaccine. She works at a nursing home. She had some fatigue and tiredness during the day but woke up on the second day without any symptoms. On 1/30/2021, she developed bilateral eyelid swelling. The swelling is mild to moderate intensity involving the upper and lower eyelids bilaterally with a prickly burning sensation associated with pruritus. The reaction lasted less than a day and resolved without any skin desquamation, scarring or bruising. She denies any hives anywhere else. She does not have a large local reaction at the injection site. She denies respiratory complaints, GI symptoms, lightheadedness, loss of consciousness, wheezing, swelling of her throat or other symptoms consistent with anaphylaxis. She used Benadryl with significant improvement. She had a significant reaction after influenza vaccination consisting of swelling of her face and her eyelids with development of dry patches bilaterally within 2 days, resolving with skin desquamation. The reaction lasted for 1 week. She received her influenza vaccination in October 20, 2020. She was seen in our office in 2012 for bilateral eyelid angioedema with associated urticaria shortly after swimming in the pool. She was given oral antihistamines ?Zyrtec once daily? with significant improvement as well as prevention of this reaction. She has not had this reaction for more than 6 years.

I got my vaccine at 5:15pm on 1/14/2021. At 5:20pm on 1/14/2021 my heart started racing. My heart rate went up to 124 beats per minute. I was having flushing, tingling through my whole body. My blood pressure went up to 139/96. I was having itching and blotchiness on my chest, neck, left arm and thighs.This lasted for 3 hours with my heart rate going up and down. I was sent to the ER by the nurses who gave my vaccine. There they gave me Benadryl. 2 tablets of 25mg each. This helped and I was sent home.

2 episodes of vomiting; Pain/redness/tenderness/swelling injection site; Pain/redness/tenderness/swelling injection site; Pain/redness/tenderness/swelling injection site; Fever of 100.0; Chills; Extreme fatigue; Headache; Muscle aches; Nausea; This is a spontaneous report from a contactable other healthcare professional (patient). A 26-year-old female patient received 1st dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), intramuscular in left arm on 18Dec2020 10:00 at single dose for COVID-19 immunisation. Medical history included covid-19 from Oct2020 to an unknown date. No known allergies. The patient was not pregnant. Concomitant medication included ethinylestradiol, norethisterone acetate (JUNEL FE 1/20). No other vaccine received in four weeks. The patient experienced fever of 100.0, chills, extreme fatigue, headache, muscle aches , nausea and pain/redness/tenderness/swelling injection site on 19Dec2020 13:00, 2 episodes of vomiting on 19Dec2020 23:45. Patient received tylenol as treatment. No COVID tested post vaccination. The patient underwent lab tests and procedures which included body temperature: 100.0 on 19Dec2020, Covid test: positive in Oct2020. The outcome of fever of 100.0, chills, headache, muscle aches was recovered on 20Dec2020, nausea was recovered on 21Dec2020, extreme fatigue and pain/redness/tenderness/swelling injection site was recovered on 22Dec2020, 2 episodes of vomiting was recovered on an unspecified date. This case was reported as non-serious.

Injection site redness; rash on arm near injection site; fever in arm; chills; nausea; This is a spontaneous report from a contactable other health care professional. A 26-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EJ1686), intramuscular on 31Dec2020 07:30 at single dose at arm left for COVID-19 immunization. Medical history included GERD, ovarian cysts, obesity, and anxiety. Concomitant medications included fluoxetine, omeprazole, and folic acid. On 11Jan2021 07:00, the patient experienced Injection site redness, rash on arm near injection site, fever in arm, chills, nausea. The patient did not receive treatment for the events. The outcome of the events was recovering.

11:01 blotchy rash on L neck w/ pulsing sensation L neck. Anxiety, sense of impending doom. BP 167/98. Cap refill slow (recorded at 45 seconds). 11:05 25mg benadryl PO 11:09 mild chest pressure without SOB, no throat tightening or difficulty swallowing. 11:25 new R neck itching/rash and chest rash 11:30 another 25mg benadryl PO 12:00 increased rash across torso and back, BP 173/80 Presented to urgent care by 1:00PM, BP 157/96, increasing chest pressure, rash improving. EKG 12-lead completed (NSR w/ sinus arrhythmia). Instructed to take PO Benadryl 50mg every 4hrs.

I received the vaccine at 11:56AM on 1/15/2021. L arm injection site pain/tenderness which increased over the course of two days. At approximately 12:30AM on 1/16/2021, extreme nausea, vomiting, fever, chills, and muscle aches began. During the day on 1/16/2021 severe joint pain (specifically bilateral knees and hips, and spine) occurred, somewhat relieved by Tylenol. On 1/17/2021 at 1:15AM, intense nausea, vomiting, and fever occurred again. As of 9:15AM on 1/17/2021, body aches and joint pain are returning and nausea is persistent.

I started to notice some itching on my arms and chest and behind my ear so I went to the bathroom to check it out and I noticed the right side of my face was getting red and blotchy looking. I went to talk to the doctor and while I was conversing with her my tongue started to get tingly and started to swell. I took 50mg of benedryl and kept an eye on my symptoms and the tongue swelling started going down but the rash is still there.

8 days after her first Covid vaccination, pt developed arm redness and tenderness at the injection site. Exam notable for 7cm region of erythema, with central induration. region is warm, mildly tender to palpation. no severe swelling. also tender Left axillary adenopathy. no fever, chills. no systemic systems. Pt very well appearing. presentation concerning for cellulitis.

Burning when it went in, tingling left arm down to hand, left left foot. Feels like it's getting worse. Advised to see PCP.

Vaccine given 1/15/21, on 1/16 and 1/17/21 reports arm soreness "felt like my arm was being ripped off" on evening of 1/7/21 bad headache, On 1/18/21 symptoms continued and overnight into Tuesday 1/19/21 Temp 101.3 chills and aching body, headache continues.

The patient experienced itching after the first dose of the COVID-19 vaccine. Pre-medicated with diphenhydramine prior to the 2nd dose of the OVID-19 vaccine. 9 minutes after the vaccination, the patient felt itchy, flushed and received oral dexamethasone. [atient was sent out with oral dexamethasone home.

Patient returned to vaccine center approximately 30 minutes after being discharged(initially waited 15min with no symptoms)-upon return patient c/o initial tingling to lips and then itching across face. Treated with 25mg Benadryl, monitored for 40 min. Vital signs remained stable and patient stated that she felt better upon leaving the center.

generalized body soreness.; severe migraine; severe weakness; left arm (same arm she received vaccine) broke out in a red itchy rash; red itchy rash; feeling hot; dry heaving; severe painful coughing; severe painful coughing lasted about an hour along with post nasal drip appearing; within 2 hours my skin became blotchy and itchy; within 2 hours my skin became blotchy and itchy; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0142 and expiry date: unknown), via an unspecified route of administration on the left arm on 05Jan2021 17:30 at a single dose for COVID-19 immunization. Medical history included autoimmune progesterone dermatitis, Reynaud's syndrome, skin mottling, gastrooesophageal reflux disease (GERD), migraines, post-traumatic stress disorder (PTSD), sulfa allergy, and depression. Patient was not pregnant. The patient's concomitant medications included PEPCID. The patient previously took progesterone, miconazole and hydroxychloroquine sulfate (PLAQUENIL) and experienced allergy.The patient experienced within 2 hours her skin became blotchy and itchy on 05Jan2021 18:45. She took a shower and symptoms resolved. Next morning on 06Jan2021, patient's left arm (same arm she received vaccine) broke out in a red itchy rash. She took Prednisone 40mg around 10am and rash resolved. Around 3-4pm the rash reappeared along with feeling hot on the same day. She ran outside and began dry heaving and coughing. The severe painful coughing lasted about an hour along with post nasal drip appearing on 06Jan2021. During that hour patient took Zofran,12 puffs of Albuterol total, and Benzedrex nasal spray. She was already on Pepcid 20mg- 2 tablets BID for GERD prior to reaction; cough improved. On 07Jan2021, around 2-3am morning woke up with a severe migraine and cough returned along with severe weakness. Patient went to the clinic she worked and received steroid shots to help along with Maxalt and more Albuterol. By Sunday, 10Jan2021, she was almost back to base like, generalized body soreness. Monday (11Jan2021) back to base line for the most part. The patient underwent lab tests and procedures which included nasal swab: negative on 08Jan2021. Outcome of the events was recovered with sequel. The reporter considered the events as non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and had been tested since the vaccination.

After the first shot of Pfizer, I started to have cold sore ( never have cold sore before). I started to take cold sore shield pills one a day and using abreva to treat cold sore. While I am still treating cold sore, I received 2 nd dose of Covid. After exact 1 week of 2nd shot, I had an allergy reaction. I was driving to work and had hive throughout of face, neck and torso. Unknown the cause, no new cream/regime for face, no new food, and no other new medications. Beside hives and itchiness, no other upper respiratory distress s/s. The hives went away after 30 minutes.

Jan 11th- by 11PM felt fatigue, muscle aches, febrile, nauseous, and chills. Jan 12th- Fatigue, soreness at injection site, and chills. Jan 13th- chills and fatigue. Jan 16th- febrile, body aches, and chills Jan 17th- febrile, fatigue, body aches and chills. Jan 18th- febrile, fatigue, body aches and chills Jan 19th- febrile, fatigue, body aches, chills, sore throat, left ear pain and nausea. Jan 20th- sore throat, body aches, fatigue, hives

Symptoms within first 6-24 hours of receiving 2nd dose: moderate pain at injection site, body/muscle aches, chills, intermittent headache and fatigue

Hives noted the following morning that were described as red, hot and itchy. Located on chest, head, hands and arms, side of right hip. Used Claritin and ice packs with some relief. Also experienced numbness on her left shoulder and left chest to navel which subsided by mid day. No breathing issues or any additional signs or symptoms.

Itching; Nausea; Headache; Body ache; Site soreness and swelling; Site soreness and swelling; This is a spontaneous report from a contactable nurse. A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EH9899), intramuscular in right arm, on 21Dec2020 at 19:45, at a single dose, for COVID-19 immunization. The patient's medical history included sciatica. The patient's concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The facility where the most recent COVID-19 vaccine was administered was a hospital. After the first dose on 21Dec2020 (from the day of injection and for 2 days post), the patient experienced itching, nausea, headache, body ache, and site soreness and swelling. Treatment was received for the adverse events which included paracetamol (TYLENOL) at 500 mg. Since the vaccination, the patient has been tested for COVID-19. Polymerase chain reaction (PCR) nasal swab for COVID-19 that was negative on 04Jan2021. The patient recovered from the events in Dec2020. No follow-up attempts are possible. No further information is expected.

Sore injection site; This is a spontaneous report from a contactable pharmacist (patient). A 26-years-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 08:45 at single dose on right arm for covid-19 immunisation. Medical history included asthma. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). No Covid prior vaccination. The patient previously took bactrim and experienced drug hypersensitivity. The patient experienced sore injection site on 24Dec2020 12:00. Outcome of event was recovered. No treatment received. No covid tested post vaccination. Information about Lot/batch number has been requested.

Patient received vaccine and left the clinic. The patient saw the charge nurse approx 45 mins to 1 hour later while the charge was eating lunch on plaza and c/o of face swelling/feeling flushed. RN walked patient to ER. In the ED, pt reports bilateral eye swelling, facial redness, scratchy throat. Pt initially felt SOB but breathing ok now. No tongue swelling.

26 y/o woman w/ no sig pmhx, c/o left sided facial numbness/tingling s/o covid vaccine. Pt states she received her vaccine at 3pm, approx 1-2 hrs later started to notice left sided lip numbness that radiated to her left ear and left side of head. No difficulty speaking, no facial heaviness, no changes in vision or hearing. No n/v, no fevers. No previous similar episodes. ED states low suspicion for any stroke, states may be an early bell's palsy vs a pre-rash zoster. Unlikely to be reaction to vaccine. Some slight improvement during ED stay.

Within five minutes I felt very faint and dizzy along with nausea. Then came the shortness of breath and the feeling of pins and needles which also brought itching and some minor hives with it. The dizziness, nausea, and feeling of fainting went away after about 10 minutes and I had to go to the Emergency Department to take care of the shortness of breath and hive like reaction. I was given some medications and they diagnosed it as a moderate allergic reaction to the vaccine. I was completely fine with the first one.

all over itchiness, no rash or bumps, intermittently itchy all over body when L arm is itchy, a mosquito bite size bump appears but subsides within 30 minutes after itching area

Maculopapular rash presented on neck and jaw approximately 6 hours following vaccination. Slightly pruritic, no other symptoms noted. Resolving at the time of this report, following hydrocortisone cream application - approximate duration of 48 hours.

Within 24 hours of getting my 2nd COVID vaccine, I began to feel weak and achy. My neck and face got really hot while the rest of my body stayed cold. A small headache began to turn into a migraine. During the night, my body began to hurt beyond achy causing me to toss and turn. When I woke up in the morning, I couldn't stand even the littlest of pressure placed on my body. For example, my cat jumped on my leg and it felt like someone wacked me with a baseball bat because of how sensitive my body was. The only treatment used for myself during this time was Tylenol. It helped with the head aches. Overall, it took me about three nights to actually feel ok again.

Reported dizziness, cold extremities, redness in left ear and rash on left shoulder noted. Mild anxiety. 25 mg Benadryl po administered. Returned to work at 10:25 am. No reaction to first dose reported.

Swelling redness and soreness at injection site; Swelling redness and soreness at injection site; Swelling redness and soreness at injection site; body aches; low grade fever; First dose on 21Dec2020, second dose on 05Jan2021; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 05Jan2021 at single dose for covid-19 immunization. The patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination. The patient had no known allergies. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number EH9899 on 21Dec2020 07:45 PM, at age of 26 years old, via Intramuscular in right arm for covid-19 immunization and experienced itching, nausea, headache, body ache, site soreness and swelling. Medical history included sciatica. The patient's concomitant medications were not reported. The patient experienced swelling redness and soreness at injection site, body aches, low grade fever all on 05Jan2021 with outcome of recovered in Jan2021. The patient underwent lab tests and procedures which included PCR nasal swab for COVID-19 negative on 04Jan2021. The patient received paracetamol (TYLENOL) 500mg for treatment. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

severe pain in left arm/neck/rib; severe pain in left arm/neck/rib; severe pain in left arm/neck/rib; Nausea; body aches; Cold and hot flashes with rigors; Cold and hot flashes with rigors; Cold and hot flashes with rigors; significantly warm to touch; Fatigue; lethargy; site of pain; This is a spontaneous report from a contactable nurse (patient). A 26-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL0142; expiration date: unknown), via an unspecified route of administration left arm on 04Jan2021 19:45 at a single dose for covid-19 immunization. Medical history included asthma and sulfa drug allergies. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medication included albuterol [salbutamol] (ALBUTEROL), montelukast sodium (SINGULAIR) and vitamins nos (MULTIVITAMIN). The patient has not had other vaccine in four weeks. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EK5730; expiration date: unknown), via an unspecified route of administration left arm on 16Dec2020 06:30 AM at a single dose for covid-19 immunization which had no reaction other than slight tenderness at injection site. The patient received her vaccine in a hospital. The patient reported that within approximately 12 hours of second dose, she had severe pain in left arm/neck/rib. The pain was spasm-like and tight. She mentioned that the nausea was related to periods of pain. The patient had cold and hot flashes with rigors. The patient mentioned that she did not have access to thermometer, but significantly warm to touch. The patient added that she has fatigue /lethargy and body aches. It was reported that the systemic symptoms resolved within 24 hours while the site pain. Interventions done by the patient included acetaminophen, ibuprofen and ice pack to site of pain. The patient has been tested post vaccination, a nasal swab which was negative on 06Jan2021. The outcome of the events was recovered on Jan2021.

in the injection site she has a "large mass hard and stiff"; large mass and it hasn't resolved. The area was really hard and stiff; breastfeeding; breastfeeding; This is a spontaneous report from a contactable consumer (patient). This consumer reported information for both mother and baby. This is the maternal report. A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL1284, expiration date not reported) via an unspecified route of administration on the left arm on 07Jan2021 07:00 at a single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. She received the first dose of the vaccine on Thursday and in the injection site she has a "large mass hard and stiff", she's concerned about this and she would like to know what she can do. In the injection area a large mass and it hasn't resolved. The area was really hard and stiff. Wanted to know if she should be concerned or be seen. Received the first dose on 07Jan2021 and kind of had this issue with the injection arm all week and maybe noticed it Tuesday because she was afraid to sleep on that side. No history of problems with vaccines in past. She is due for the second dose on 28Jan2021. Caller later provides that she is breastfeeding at the moment, but no further details provided. The events did not result to a physician office and emergency room visit. Vaccination Facility Type was hospital. There were no additional vaccines administered on same date of Pfizer suspect. No relevant tests done and no family medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Event was reported as non-serious. Outcome of the events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021051752 mother/baby

Fatigue for 2 and half days. Increased blurred vision while driving and watching television. Tender at injection site.

Body aches, upset stomach, mild chills: lasted ~8hrs Headache: lasted ~12hrs Sore arm (injection site): ~42+hrs (still mild discomfort at this time)

Severe headache, nausea, all-over muscle pain, joint stiffness, fatigue, temp went up but not enough for a fever. I took Bayer for the muscle pain and slept. Developed soreness of injection site approximately an hour after injection. Muscle stiffness and joint pain began that night. Other symptomst started Thursday morning and ended Friday morning.

Muscle ache localized to the right arm, shoulder and neck. Significant tenderness in R deltoid (injection site).

Pfizer COVID- 19 Vaccine Pt received Pfizer COVID vaccine lot #EL3249. Pt sat for about 10 minutes, arm became itchy, gave diphenhydramine x 1 dose. Pt continued to sit for assessment for another 15 min. Pt stated she felt hot, but is typical for her to feel warm. No chest pain, SOB, blurred vision. Pt cleared to leave facility.

Following 1st COVID-19 vaccination she began having generalized fever, body aches, fatigue, and near syncope prompting her to go to the ED, 2 days after the vaccine. She also began having diffuse swelling of the LUE and L chest wall. Swelling down to elbow prior with erythema and mild rash, which I visualized in a photo. Unsure if blanched. Resolved over several days and was without symptoms when I saw her. Had IV in AC area for IVFs on impacted side but denied symptoms of infiltration.

I experienced sweating, chills, fatigue and sore at the injection sight. I was sore at the injection site right after it was administered. I then experienced severe chills in the evening, starting at about 7pm. The next morning I woke up fatigued and alternated between sweating and having the chills and shaking.

Intense itching palms, soles of feet, axilla, inner forearms, wrists. Lasting from 1/23/21 to present and has not resolved. No change in laundry detergent/soaps/lotions, no known allergies, no medication changes recently.

Pt presented 24 hours post COVID-19 vaccine (Pfizer) with systemic rash which was pruritic. Multiple lesions on trunk, axilla, groin which appeared pus pustular seen at clinic, prescribed Zyrtec, antifungal cream and hydrocortisone cream. I discontinued the creams and placed on oral steroid burst. still no improvement.

Patient's reaction(s) noted during COVID vaccine observation period: hives and redness/itching to sides of abdomen. No sob, chest pain noted. Actions Taken: Vital signs taken, observed for 30 minutes. Advised to monitor rash at home and take antihistamines as needed. Patient verbalized understanding. Disposition: Home

tenderness at injection site; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EK5730, unknown expiration), via an unspecified route of administration in left arm on 16Dec2020 at 06:30 AM at a single dose for COVID-19 immunization in a hospital. Medical history included asthma and allergy to sulfa drugs. Concomitant medications included albuterol, montelukast sodium (SINGULAIR), and unspecified multivitamin. The patient reported that she has no reaction after receiving the first dose other than slight tenderness at injection site in Dec2020. The patient did not receive other vaccine in four weeks. The patient has no COVID prior to vaccination and was tested for COVID post vaccination. The patient underwent lab tests and procedures which included nasal swab: negative on 06Jan2021. Outcome of the event was unknown.

Blisters around hips, thighs, and elbows.; Intermittent chest pain and tightness; Intermittent chest pain and tightness; shortness of breath; Swollen lymph nodes under bilateral arms that have not decreased; Chills; sweating; Headache; This is a spontaneous report from a contactable nurse (patient). A 26-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number= ELO140), via an unspecified route of administration at left arm on 14Jan2021 12:00 at single dose for covid-19 immunization. Medical history included known allergies: cephalosporins, coconut. Other medical history was none. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Jan2021 at time of 05:00 AM, the patient experienced blisters around hips, thighs, and elbows; Intermittent chest pain and tightness with shortness of breath beginning one day after vaccine and continuing into day 4 DOST vaccine, swollen lymph nodes under bilateral arms that had not decreased, chills and sweating, headache. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient underwent lab tests and procedures post vaccination which included COVID nasal swab test and COVID PCR test, both were negative on 14Jan2021. The outcome of events was not recovered.; Sender's Comments: The reported blisters around hips, thighs, and elbows; Intermittent chest pain and tightness with shortness of breath beginning one day after vaccine was probably related to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) due to temporal relationship. The case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.

Muscle aches, weakness, fever, chills, slightly swollen face and lymph nodes, injection site pain, feeling unwell, fatigue.

Itchy neck, head, back and knees. Was released to go home and take Benadryl. Headache later that night into Sunday and Monday. Chills and muscle aches

The patient experienced itching after the first dose of the COVID-19 vaccine.; This is a spontaneous report from a contactable pharmacist. A 26-year-old female patient (not pregnant) received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL0140), intramuscularly on 20Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced itching after the first dose of the covid-19 vaccine in Dec2020 with outcome of unknown.

A few hours later around 1:00 pm the bumps began to turn pink and red, similar to hives; A few hours later around 1:00 pm the bumps began to turn pink and red, similar to hives; woke up with bumps on both of the arms; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 16Jan2021 12:30 at a single dose on left arm for COVID-19 immunization. Medical history included asthma, osteoarthritis, allergies: general anaesthesia. The patient was not pregnant. Concomitant medication included phentermine and vitamin D3. On 17Jan2021 at 10:00 am the patient woke up with bumps on both of the arms. A few hours later around 1:00 pm the bumps began to turn pink and red, similar to hives. Patient began to take Benadryl twice a day. On 18Jan2021 at 6:00 am the hives began to appear on both arms again and back. On 19Jan2021 the patient woke up at 6:00 am and the hives appeared on both arms, back, chest, stomach, both legs, neck and parts of the face. Therapeutic measures were taken as a result of rash papular and urticaria which included Benadryl, while no treatment received for skin disorder. The outcome of the events was not recovered. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Facility type vaccine was other. No other vaccine in four weeks. No COVID prior vaccination. Not COVID tested post vaccination. Information on lot/batch number has been requested.

I am a pharmacist for pharmacy and received my first dose of Pfizer Covid-19 vaccine while at work by another pharmacist. Vaccine given around 2:15 PM on 2/2/21 Less than 5 minutes after vaccine - arm tingling at site of injection, arm tingling spread from injection site to fingers, tingling and pins/needles traveled through underarm area and moved across left side of chest, slight chest pain on left side, whole body started tingling, dizziness, racing heart. While experiencing all of these symptoms, I sat on the ground, took two tablets of 25mg Benadryl, drank water, and tried to breath steady to make dizziness go away. Working in this healthcare setting, I was aware I was having an adverse reaction to the vaccine and was prepared with an epi-pen in case of any severe anaphylaxis shock - I did NOT have to use the epi-pen. Less than 15 minutes after vaccine - the chest pain, arm pins/needles stopped, I felt lightheaded still, another co-worker checked my blood pressure which had risen to 178/120 and pulse of 120. About 1 hour after vaccine - still felt light headed, blood pressure still elevated at 158/107, pulse of 107. Around 5:45 PM - After consulting personal friend physicians, I was instructed to go to ER and have an EKG of my heart since my blood pressure and pulse had spiked so high and suddenly. I was able to find coverage at work so that I could leave my shift and get a ride to the emergency room. After 6 PM (admitted into ER) - upon admission blood pressure of 176/117 and pulse of 113

Mild injection site soreness; more tired than usual which extended into the following day; This is a spontaneous report from a contactable consumer (patient's parent). A 26-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 12Jan2021 11:00 to 12Jan2021 11:00 at SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication included etonogestrel (NEXPLANON). On 12Jan2021, the patient had mild injection site soreness and 3-4 hours after receiving the vaccination and noted being more tired than usual which extended into the following day. The events were assessed as non-serious as per the reporter. The patient did not received any treatment for the events. The patient is not pregnant at the time of the report. Outcome of the events was recovered on an unspecified date. Information on the lot/batch number has been requested.

small bump at site with redness and mild itchiness; small bump at site with redness and mild itchiness; small bump at site with redness and mild itchiness; This is a spontaneous report from a contactable other health professional (patient). A 26-year-old female patient was administered the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), intramuscular (left arm) on 17Jan2021 16:30 at single dose for Covid-19 immunization. The patient was administered the first dose of BNT162B2 (lot number: EL0140) on 29Dec2020 at left arm for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE). The patient previously took Amoxicillin and experienced allergy. The patient was not diagnosed with COVID-19 prior to vaccination. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Jan2021 (also reported as "day 6 post vaccine"), the patient experienced small bump at site with redness and mild itchiness. There was no treatment received for the adverse event. The outcome of events was unknown. The outcome of events was unknown. The patient has not been tested for COVID-19 since the vaccination.

Sore arm a few hours after getting the shot Next morning, sore arm, very sensitive skin, temperature of 99.7

Hives all over body, facial swelling, rapid heart rate, itching. Reaction lasted 20-30 minutes. Flu-like symptoms (fatigue, chills, runny nose) followed.

hard large lump that hurts at the injection site /Left arm has a knot in it from injection site; hard large lump that hurts at the injection site; chest pain; shortness of breath; This is a spontaneous report from contactable consumer (patient). A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration into the upper left arm on 05Jan2021 at single dose as a precaution because she works in nursing home (COVID-19 immunisation). Medical history included Covid positive back in Oct2020. Concomitant medication included biotin and one a day women's vitamin. Family members have medical issues. Dad has heart tumors, seizure, sleep apnea and osteoporosis. Mom has asthma, diabetes, has had cancer, neuropathy and macular degeneration. The patient received first dose of the covid vaccine on 05Jan2021 and had some symptoms after the vaccine. On unspecified date in Jan2021, the patient hard large lump that hurts at the injection site, chest pain and shortness of breath; similar to when she had Covid positive back in October. She still has a lump at the injection side which has gotten smaller in size but still hurts to touch. Left arm has a knot in it from injection site; does not reuired ER or visit to physician's office. It feels like a bump with something in her arm. She doubts that is the case. She wanted to see if that was normal and when it might go away, especially since she should be getting second dose on 26Jan2021. She is a speech therapist. There is no prescriber. They came and gave to everyone all at once. It was really big at first. It felt like someone punched her. It was a big giant lump, but it is getting better. The injection was given in the upper left arm and it felt like it went into the muscle. The outcome of the event vaccination site mass was recovering, and the outcome of the remaining events was unknown.

arm pain at the injection site; fever (100 degrees F) later that night lasting into the next day; This is a spontaneous report from a non-contactable consumer. A 26-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number EK9231) intramuscularly on 20Jan2021 (at the age of 26-years-old) at 0.3 mL as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received dose 1 of BNT162B2 intramuscularly on 30Dec2020. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 21Jan2021 at 00:00, the patient experienced arm pain at the injection site and fever (100 degrees Fahrenheit (F)) later that night lasting into the next day. The patient did not receive any treatment for the events. There was no hospitalization for the events and the reporter assessed the events as non-serious. The clinical outcomes of arm pain at the injection site and fever (100 degrees F) were not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.

itchiness; Injection site reaction of firmness beneath skin; Injection site reaction of swelling; Injection site reaction of redness; Injection site reaction of warmth; Injection site reaction of soreness; This is a spontaneous report from a non-contactable pharmacist (the patient). A 26-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL3247), via an unknown route of administration in the left arm on 19Jan2021 at 16:30 (at the age of 26-years-old) as a single dose for Covid-19 immunization. Medical history included skin of upper arm is affected by mild eczema/atopic dermatitis, keratosis pilaris, hypertrophic scarring all from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was allergic to latex which causes a rash/ swelling. The patient's concomitant medications were not reported (did have other medications in two weeks, unspecified). The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 20Jan2021 reported as for first day, the patient experienced Injection site reaction of firmness beneath skin, swelling, redness, warmth, soreness and on the second day also experienced itchiness. The patient did not receive any treatment for the events. The clinical outcome of the events vaccination site induration, vaccination site swelling, vaccination site erythema, vaccination site warmth and vaccination site pain was not recovered; pruritus was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.

The vaccine was inadequately administered, too deep and too high, into the shoulder bursa. The patient developed sharp pain soon after which persisted for two days. Soon after she started with neurological symptoms including increased sweating in the affected arm, pain in the branchial plexus region, including arm and forearm, paresthesias in arm, forearm, and fingers, sensation of scapula being dislocated, and tightening sensation in the lateral aspect of the chest. Symptoms are worsening every day. There is a high suspicion that she is developing Parsonage-Turner syndrome.

Hives, diffuse over body. Intense itching on hands, legs, stomach, scalp, chest, and neck. Would welt up then disappear and then reappear. Start time 3:00pm 2/5/21 and is ongoing. Antihistamines and IM 4mg decadron shot taken. Helped for a time but symptoms have proceeded.

Felt fine until 12 hours after 2nd dose - extreme nausea and vomiting, high fever, alternating chills and sweats for ~6 hours. 40 hours after dose, woke up and had several painful bumps on vulva and labia- small and white, slight redness around them. No history of STDs, more than a year since last sexual activity. Did some googling to figure out what it was and closely matched what was described/photos in this paper .Searched "aphthous ulcers vulva" to confirm using more photos, and determine treatment/if I needed a doctor, and came across a web site, which then led me to believe they bumps were related to the vaccine. Treated with over the counter hydrocortisone 1% every 12 hours for a total of 4 applications, and bumps are mostly painless and reduced in size.

Patient had itching/redness at the injections site (Left arm). Developed hives on the right arm. No itching in throat. Patient was given diphenhydramine 12.5 mg.

Pfizer-BioNTech COVID-19 Vaccine EUA: Patient vaccinated at COVID-19 Vaccine Center. They were brought to observation area and proceeded to have hives and reddening of face, neck and injection site. BLS (EMS) treated patient on site and patient escorted out via wheelchair.

Description of adverse event - Upon disrobing in order to shower for the evening, I noticed a rash, primarily on my torso, but also on my arms. I had not noticed it before this time. I had not noticed itching or any other side effects other than the (expected) arm pain. Treatment - 50 mg of Benadryl Outcome - rash is still present at this time (11:05 PM, Monday 2/8)

rash going down her arms; This is a spontaneous report from a contactable consumer. A 26-year-old female patient received bnt162b2 (BNT162B2), lot number not reported, via an unspecified route of administration from an unspecified date to an unspecified date at SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced rash going down her arms on an unspecified date with outcome of unknown. Information on the lot/batch number has been requested.

Event #1: I experienced a small outbreak of hives on my left cheekbone within 15 minutes of receiving the vaccine. The staff gave me an injection of Benadryl into my right arm. The spot reduced in size over the duration of an hour and I was sent home with instructions to take OTC Benadryl until the swelling disappeared completely later that evening. Event #2: Shortness of breath and chest tightness beginning exactly 74hrs after the vaccination (Sunday, 01/31/2021 at 2:15pm). This side-effect continues to persist and is not due to a true Covid-19 infection.

Nausea; Fever; Chills; Body aches; Lethargy; Injection site inflammation and swelling; Injection site inflammation and swelling; This is a spontaneous report from a non-contactable healthcare professional reporting for self. This 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL9261) on 20Jan2021 10:00 AM at single dose (vaccine location=left arm) for COVID-19 immunisation. Medical history was none. No known allergies. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (lot number=EL0140) on 30Dec2020 07:15 PM at single dose (vaccine location=left arm) for COVID-19 immunisation. The were no other vaccine in four weeks, patient did not have COVID prior vaccination. Patient was not pregnant. The patient experienced nausea, fever, chills, body aches, lethargy, injection site inflammation and swelling on 21Jan2021. No treatment received. Patient did not test COVID post vaccination. The outcome of events was recovered in Jan2021. No follow-up attempts are possible. No further information is expected.

Soreness at injection site as well as anterior shoulder pain. Soreness at injection site resolved., but continues to have anterior shoulder pain.

After the 15 minutes in observation, the patient called by phone to inform she was experiencing body itching and throat.

These symptoms started the evening of my vaccine and lasted for 4 days (1/28/2021 through 1/31/2021). Uncontrollable chills, severe body aches, upper/middle back pain, neck pain/stiffness, extreme fatigue, ear aches, raging frontal and occipital headache, and hives (white in color on both legs - inner knee area), itchy neck and chest. Benadryl taken for hives. Ibuprofen taken for other side effects. No treatment/OTC medication provided real relief until late evening of day 3 after vaccine. Hives and side effects resolved entirely after 4-5 days post-vaccine. White hives turned into red healing rash-like bumps and eventually disappeared entirely.

complaint of palms of both hands turning red, her right palm started itching, left palm started tingling. patient given Benadryl 50 mg PO x once. Redness reduced; itching and mild tingling of hands persisted.

dizziness; cold extremities; redness in left ear; rash on left shoulder; Mild anxiety; This is a spontaneous report from a contactable pharmacist. A 26-year-old female patient received the second dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EL3302), intramuscular at the left arm on 26Jan2021 11:00 at a single dose for covid-19 immunization. The vaccine was administered in a hospital. The patient's medical history and concomitant medications were not reported. It was unknown if the patient was pregnant at the time of vaccination. Historical vaccine includes first dose of bnt162b2 on 05Jan2021 10:15 AM, lot number: EL1284, intramuscular at the left arm for COVID-19 immunization at the age of 26 years. No reaction to first dose was reported. On 26Jan2021 11:00, the patient experienced dizziness, cold extremities, redness in left ear and rash on left shoulder noted and mild anxiety. Oral 25 mg Benadryl was administered. Returned to work at 10:25 am. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was recovered on 26Jan2021.

first dose was administred on 28Dec2020 and second dose on 21Jan2021; Sore arm at injection site; body aches during the second shot for a full 24 hours; This is a spontaneous report from a contactable pharmacist (the patient). A non-pregnant 26-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3302), via an unspecified route of administration, in the left arm on 21Jan2021 as a single dose for COVID-19 immunization. Medical history included asthma. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included spironolactone, ethinylestradiol, levonorgestrel (AVIANE), cholecalciferol. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine include the first dose of BNT162B2, lot #EK9231, intramuscular in the left arm on 28Dec2020 at the age of 26-year-old for COVID-19 immunization. On 22Jan2021, the patient experienced sore arm at injection site, (but not as severe in comparison to the flu shot), and body aches during the second shot for a full 24 hours. The events were reported as non-serious. Treatment for the events included acetaminophen 500 mg - 2 tablets by mouth twice daily. The clinical outcome of the events sore arm at injection site, and body aches during the second shot for a full 24 hours was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Persistent migraine. My headache began about 3 hours after and stayed mild until about 30 hours later where it grew to a migraine. It is not day 8 since the vaccine and it has not gone away. In addition to the migraine I am experiencing light sensitivity, blurred vision, and yesterday I experienced some heart palpitations. I went to urgent care on 2/8 and was prescribed IC Butalb-Acetamin-Caff for the migraine symptom. In addition I have been taking tylenol and advil which are not helping. My injection site pain and brain fog have resolved while the headache has persisted.

Hives on lips - tiny red bumps on outer edge of top and bottom lips, swollen lips - both top and bottom, both lips bright red

Fever, severe pain at injection site, muscle and joint pains all over, fatigue, weakness, headache. Took Tylenol and rested

Abdominal rash/hives that is itchy, hives on neck, back and Left elbow crease. SOB with daily activities. Lightheadedness. Symptoms began 3 days post 2nd vaccine and continue to progress.

Chills- night of vaccine all the way through the next day 2/13 Muscle aches & exhaustion- 2/13/21 lasted all day for one day. Required extra sleep + acetaminophen & ibuprofen Hives- Woke up 2/14 will small itchy patches all over the body (shoulders, back, stomach, legs, hands, feet). Took benadryl for treatment. Still itching all day 2/15/21 Sharp chest pain 2/14. Pain started halfway through the day and throughout the night. OTC pain medication had no effect. Disappeared after sleeping and waking up on Monday 2/15 Swollen lymph node in the left armpit (vaccine arm)- slight pain/tenderness. Started 2/14 in the morning. Still slightly tender as of end of the day 2/15

I developed cold urticaria the day following receiving the second dose of the COVID vaccine, I know develop hives when outside in temperatures <37 degrees Fahrenheit and swelling and hives when touching cold objects. I was seen by a doctor who diagnosed this condition, and he believes it is directly related to the COVID vaccine.

I received my COVID19 vaccines on 12/31/2020 and 1/21/2021. On 2/3/2021 I woke up with pain, swelling, redness, and decreased range of motion in my R elbow at the site where I had hardware (wires, pins, tension band) placed during a surgical repair of my olecranon process in 2013. I have never had any issues with this elbow since the surgery, and no illnesses/dental work/medication changes in the months before this. The only change was getting my COVID vaccine. I went to see my PCP Dr. who advised me to go to the ER due to fear of a potential infection based on these symptoms. I went to the ER and after extensive testing they ruled out this being an infectious cause, though I was put on PO doxycycline as a precaution. An orthopedic specialist came to see me and determined that my body is essentially rejecting the hardware and I need to have surgery to have it removed. Since then, the swelling has decreased, however I still have persistent pain in my elbow along the site where the hardware is inserted and limited mobility due to pain with certain movements that put tension on this joint. I will need to have surgery eventually to have the hardware removed but am hoping to wait a couple months so that I can complete nursing school. I was advised to report any potential side effects from this vaccine and am choosing to do so as I do not know of any other reason this could be happening.

Diffuse, red, splotchy rash all over her torso, upper thighs (front and back), spreading below knees. Morbilliform in appearance. Rash does not itch, but it burns per patient report.

Swelling and redness at injection site, about 3 inches in diameter. Swelling subsided 5 days after shot, but returned after day 9. No pain.

RECEIVED BOTH DOSES OF FPIZER COVID-19 VACINE ON 01/27/21 & 02/17/21. CALLED EMPLOYEE HEALTH HELP LINE ON 02/18/21 ABOUT ADVERSE VACCINE REACTION INCLUDING FEVER, COUGH, FATUGUE,, HEADACHE, MUSCLE ACHE, RED RASH, SWELLING AT INJECTION SITE. CALLED EMPLOYEE HEALTH HELP LINE ON 02/19/21 REPORTING MUCLE ACHES AND LOW GRADE TEMP, STILL WITH IN EXPECTED 48 HRS SINCE VACCINATION. CALLED EMPLOYEE HEALTH HELP LINE ON 02/20/21 REPORTING HIGH RISK EXPOSURE TO COVID-19, CONTINUED HEADACHE, RUNNY NOSE, BUT OTHER PRIOR VACCINE REACTIONS REPORTED AS RESOLVED. REPORTED ON 02/20/21 COMPLKAINING OF HEADACHE AND DRAINAGE. TSTD NEGATIVE FOR COVID19. DIAGNOSED WITH HEAD CONGESTION.

Area of red raised bumps in the shape of a square directly below injection site with accompanying pruritus. Onset is not known however, first noticed it 2 days after injection.

Anaphylaxis - tachycardia, palpitations, shortness of breath, skin itching. Received epi pen and ER transport. Now undergoing allergy testing.

Pt came in to have 2nd vaccine pt started to notice her arm itching and saw hives PT alerted us and was taken in medical evaluation room where she was given 50 mg of benadryl Pts hives went away with no other reaction Pt left via POV

Developed red hives around neck and chest at 4 minutes post vaccination. Gave 25 mg tablet Benadryl PO. At 7 minutes post vaccination had c/o feeling warm and having a headache. Vitals taken, vitals repeated 5 minutes later, still had c/o headache and feeling warm, chest hives redness was decreasing however, she was starting to itch on her back. At 11:15 an additional 25 mg tablet of Benadryl PO was given.

Orange-ish yellow color appeared on hands (color of iodine) was noticed on Saturday Night 2/20/21 and lump developed above left clavicle noticed Sunday Morning 2/21/21. No treatment was performed.

Patient complained of tingly lips, itchy left arm (near vaccine site). Patient waited 30 minutes with improvement of symptoms and left the site.

Facial hives/hives on the face; might have caused a flare of my kidney disease; might have caused a flare of my kidney disease; This is a spontaneous report received from a contactable consumer (patient herself). A 26-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9264), via an unspecified route of administration on 27Jan2021 09:45 on left arm at single dose for COVID-19 immunisation. Medical history included liver transplant and kidney disease. The patient previously took amoxicillin and had allergies. The patient did not receive other vaccine in four weeks prior to vaccination but received other medications (unspecified) in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 27Jan2021 12:00, the patient experienced facial hives/hives on the face and reported that it might have caused a flare of my kidney disease. The seriousness of the events was considered as non-serious by the reporter. Therapeutic measures were taken as a result of event facial hives/hives on the face included Benadryl. The outcome of the event hives was recovering, whereas unknown for other events.

830am given, 1015am facial numbness and tongue tingling. Slurred speech. Itching and burning sensation internally. Medications to stop allergic reaction given by IV. Discharged home. Slight fever currently, muscle and body aches and pains. Joint pain. Headache.

Swollen Lymph nodes following second dose x five days; Large lump underneath left armpit expanding into left breast formed and caused limited ROM and immense pain and bruising; Large lump underneath left armpit expanding into left breast formed and caused limited ROM and immense pain and bruising; Large lump underneath left armpit expanding into left breast formed and caused limited ROM and immense pain and bruising; Large lump underneath left armpit expanding into left breast formed and caused limited ROM and immense pain and bruising; Large lump underneath left armpit expanding into left breast formed and caused limited ROM and immense pain and bruising; This is a spontaneous report from a contactable healthcare professional (patient). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), intramuscular at the left arm on 21Jan2021 09:45 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has previously been vaccinated with the first dose of BNT162B2 (lot number: Pfizer 1284) on 30Dec2020 11:00 at the age of 26-year-old, intramuscular at the left arm for Covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient experienced swollen Lymph nodes following second dose for five days, large lump underneath left armpit expanding into left breast formed and caused limited ROM, immense pain, and bruising on 21Jan2021. The patient did not receive any treatment for the events. The patient has recovered from the event swollen lymph nodes on 26Jan2021 and recovered on an unspecified date for the rest of the events.

fever; chills; headache; overall fatigue; pain and tenderness at injection site as well as in the armpit underneath the injection site; pain and tenderness at injection site as well as in the armpit underneath the injection site; patient with autoimmune thyroiditis (not yet clear if Hashimoto's or Graves) received PfizerBiontech Covid-19 Vaccine; patient with autoimmune thyroiditis (not yet clear if Hashimoto's or Graves) received PfizerBiontech Covid-19 Vaccine; This is a spontaneous report from a contactable healthcare professional (patient). A 26-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZERBIONTECH COVID-19 VACCINE; unknown lot number and expiration date) at vaccination age of 26-year-old intramuscularly in the left arm on 26Jan2021 12:15 at a single dose for covid-19 immunization. Medical history included autoimmune thyroiditis (not yet clear if Hashimoto's or Graves), appendicectomy and pyelonephritis. The patient was not diagnosed with Covid-19 prior to vaccination. Concomitant medication included methimazole, atenolol, valaciclovir hydrochloride (VALACYCLOVIR HCL), ethinylestradiol, norgestimate (NORGESTIMATE & ETHINYL ESTRADIOL) and magnesium. The patient did not receive other vaccine in four weeks. The patient previously took azithromycin but drug allergy. The patient received the first dose of of bnt162b2 (BNT162B2 reported as PFIZERBIONTECH COVID-19 VACCINE; unknown lot number and expiration date) at vaccination age of 26-year-old intramuscularly in the left arm on 05Jan2021 02:15 PM at a single dose for covid-19 immunization but had pain and tenderness at the injection site. It was reported that the patient with autoimmune thyroiditis (not yet clear if Hashimoto's or Graves) received PfizerBiontech Covid-19 Vaccine in a hospital on 26Jan2021 12:15. On 27Jan2021 12:00 AM, the patient had fever, chills, headache, overall fatigue, pain and tenderness at injection site as well as in the armpit underneath the injection site. The events required treatment which included acetaminophen. The outcome of the events was recovering. Information on the lot/batch number has been requested.

Slight pain at the injection site; muscle and joint aches (mostly in shoulders and back) which caused difficulty sleeping at night; muscle and joint aches (mostly in shoulders and back) which caused difficulty sleeping at night; muscle and joint aches (mostly in shoulders and back) which caused difficulty sleeping at night; Slight nausea; This is a spontaneous report from a non-contactable consumer (patient). A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247), via an unspecified route of administration on 26Jan2021 at a single dose on the left arm for COVID-19 immunization. The patient's medical history was not reported. Concomitant medications included ethinylestradiol, norgestimate (ESTARYLLA), valacyclovir, cyanocobalamin (B12), iron, and colecalciferol (D3). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 26Jan2021, the patient experienced slight pain at the injection site, muscle and joint aches (mostly in shoulders and back) which caused difficulty sleeping at night, and slight nausea. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was not recovered. No follow-up attempts are possible. No further information is expected.

I got the shot on February 5th, 2021. On the day of my injection, I immediately felt a stiffness in my arm within 10 minutes of receiving the shot. I didn't think too much of it because I had some stiffness in my arm with the first shot. But this Friday - March 5th will be a month and I am still having arm issues and they have gotten worse. I never had a rash or bruise on the injection site but from the injection site I have a tenderness on my arm and a constant dull and achy pain - sometimes sharp and painful - that starts at the injection site then travels down through my elbow and into my hand. My hand will get tingly and numb as well. My arm will sometimes randomly fall asleep as well. I went to the doctor but they gave me ibuprofen and that didn't do much. I am going back to the doctor soon.

It seems like she was drunk; it was almost like disorientation like; Had trouble processing like formulating sentences; she had trouble listening and her 'attention' stammered very much; Injection site swelling; Stammer; Pain; This is a spontaneous report from a contactable consumer. This consumer reported for a 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: unknown) via an unspecified route of administration on 30Jan2021 at SINGLE DOSE for covid-19 immunisation which was administered by her employer. Medical history was none. There were no concomitant medications. The reporter stated that about 2 hours after the administration of the vaccine "it was almost like disorientation like she was kind of, it seemed like she was drunk. She had trouble processing/formulating sentences. She had trouble listening and her 'attention' stammered very much." No treatment received for reported events. The reporter reported that she seemed better now. The outcome of the reported events was recovering. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.

headache, body aches, injection site pain, GI upset and severe swelling of lymph nodes under my L arm (axillary region) at this time I have a golf ball sized lymph node in my L armpit that is tender to the touch

Soreness and swelling at injection site (right arm); Soreness and swelling at injection site (right arm); Fatigue; Nausea; Headache; This is a spontaneous report from a contactable consumer (patient). This 26-year-old non-pregnant female consumer received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN5318) via unspecified route of administration in the right arm on 27Jan2021 at 11:00 (at the age of 26-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. The patient did not have COVID-19 prior to vaccination, and did not receive any other vaccines in the 4 weeks prior to vaccination. Concomitant medications included paracetamol (TYLENOL) from an unknown date for an unknown indication; ibuprofen (ADVIL) from an unknown date for an unknown indication; and ethinylestradiol, etonogestrel (NUVARING) from an unknown date for an unknown indication. On 27Jan2021 at 21:00 the patient experienced soreness and swelling at injection site (right arm), fatigue, nausea, and headache, all lasting 24 hours after inoculation. No treatment was received for the events. The clinical outcomes of soreness and swelling at injection site (right arm), fatigue, nausea, headache, were recovered on 28Jan2021 at 21:00. It was also reported the patient did not test for COVID-19 post vaccination.

Severe injection site swelling (grapefruit size); Nose bleed; Fever of 102; Lethargy; Tachycardia; Shortness of Breath; Severe joint pain; Migraine; Muscle pain; This is a spontaneous report from a contactable other healthcare professional (HCP reporting for self). A 26-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on 27Jan2021 11:30 at a single dose in the right arm for COVID-19 immunization. Other medical history and known allergies were reported as none. The patient had no COVID prior vaccination. The patient was not pregnant at the time of the report and vaccination. Concomitant medications included zinc, ascorbic acid (VIT C), ergocalciferol (VIT D) and an unspecified birth control medication. The first dose of BNT162B2 (brand: Pfizer as reported) was received on 06Jan2021 12:00 PM in the left arm for COVID-19 immunization. The patient had no other vaccine in the four weeks prior to second dose vaccination. On 27Jan2021 23:00, the patient experienced nose bleed, fever of 102, severe injection site swelling (grapefruit size), lethargy, tachycardia, shortness of breath, severe joint pain, migraine and muscle pain. The patient did not receive treatments for the reported adverse events. Patient had COVID test post vaccination specified as nasal swab on 27Jan2021 with test result as negative. The events were reported as recovered with lasting effects. Information on the Lot/Batch number has been requested.; Sender's Comments: Considering the close drug-event temporal association and the location, the reasonable possibility that the reported severe injection site swelling is related to BNT162B2 seems likely.

hives on arms, neck on day 1. burning sensation. still hives on 3/4/21 but resolving with Benadryl, limited to arms. itchy but less severe.

Within 10 minutes of receiving the vaccine I had a flushed/hot/sun burned looking face. Within 15 minutes I had hives on my chest in back. I had high blood pressure 180/120, facial puffiness and mild bottom lip swelling. I developed an onset of increased mucus in my throat causing me to clear my throat frequently. RN on site reported no throat swelling, but increased thickness due to mucus. I received a Benadryl injection on site within 30 minutes and almost immediately symptoms began to lessen. The next day I had mild bottom lip swelling, body itchiness, chest rash, headache and fatigue. Today (24 hours after vaccine) I have a headache, fatigue and body itchiness.

Rash on neck and chest that lasted about 10-12 days ? No itching or irritation, just lots of spots. Fatigue.

Pfizer-BioNTech COVID-19 Vaccine EUA Injection site pain Intermittent Chills Intermittent headache Intermittent dizziness Fatigue Soreness in arm of injection

Day off, hives up entire arm and loss of strength in right arm. Took Benedryl to calm it. Next day, very weak and sore arm. Very little movement or strength. Third day, weak but able to slowly lift arm above head.

Increased pain and redness at injection site greater than 24 hours after vaccine. Fevers and chills. Diagnosed as cellulitis, treated with a 10 day course of antibiotics.

Pain and swelling at injection site, muscle of injected arm is achy, hard to lift even to shoulder-height, itching at injection site, body aches, headache, upset stomach/nausea (but no vomiting or diarrhea)

A week after my shot and I'm still having strange reactions. The day after the shot I started getting really bad cramps and other PMS symptoms like bloating and tenderness (even though I'm on a type of birth control that means I don't get a period). Then a few days later I started my period and has continued. I also have developed the kind of rash that I get when I eat wheat--all over my body and itchy and it hasn't gone done. Finally, it also caused a lot of digestive issues and bloating and gas. it makes me very nervous to get my next shot.

5:28pm received 1st Covid-19 vaccine. At 5:40 c/o slight throat tightness. O2 sat 99, Pulse 100, B/P 128/80. At 5:45pm c/o tongue tingling. 5:49pm hives on chest and c/o chest tightness. Denies SOB. O2 sat 99, pulse 130, B/P 124/72. 5:50pm 0.5 mg Epi administered IM left thigh and EMS activated. 5:50pm pulse 110, B/P 130/82, O2 sat 98%. Transported to hospital at 6:02pm per ambulance.

Patient had a minor reaction - reported feeling flush and hives. Patient developed symptoms at 30 min waiting period. She was given 50mg of diphenhydramine and observed for additional time. Patient reported feeling better after receiving diphenhydramine.

Mild/moderate itchiness all over the body set in after a few hours and has persisted to the current time.

Within 8 hours of receiving dose #2 of the Covid 19 vaccine, developed shingles rash on left waist, left lower back and buttock and left abdomen. The rash was red, raised with blisters. She had no fever. She was given Tylenol, and Benadryl to prevent pain and itching. At this point (10 days post vaccine) the rash appears to be healing, blisters have scabbed over and some scabs falling off.

Redness and itching noted after injection. Advised to take PO Benadryl once home. Patient has a history of itching after vaccinations

Within 10 minutes of observation post-Pfizer COVID vaccine. Pt c/o itching to lower back. The RN visualized redness along pant line, approximately palm sized. Waited 5 minutes with continued observation and patient stated continued itchiness but h/o multiple allergies. Denies SOB, no oral swelling noted, RR even and unlabored. Assessed torso with no further significant hives but previous still visible. Pt given 25 mg po Benadryl. Pt requested to go home, denied acute distress, states she has Zyrtec at home. Pt with coworker who stated pt will remain with them for next few hours and they would monitor her symptoms. Pt given s/s to monitor for, when to go to ED if acute symptoms, and to notify MD of possible allergy. Pt agreed with Plan of Care.

Patient stated that she received her vaccine in her left shoulder and then noticed a tingling of her left arm. Patient remained seated and then states that the next thing she noticed that she was being woken up by bystanders. Bystanders stated that she lost consciousness fell forward and hit her head on the floor followed by a few shaking/jerking motions and then regained consciousness after approximately 10-15 seconds. Patient denied any prodromal symptoms leading to her fall such as headaches, vision changes, lightheadedness/dizziness, nausea/vomiting, warmth, chest pain or shortness of breath. States that after waking up she noticed pain on the left side of her head where she hit her head. States that after her fall she felt fully aware denies any confused/disoriented state, tongue biting, urination or any other symptoms. Pt had a 4 x 5 cm scalp hematoma on left forehead and tachycardia. Pt was A&Ox3, was able to ambulate, and was discharged from the Emergency Department.

The night of the vaccine: body aches 24 hours later: chills, body aches 42 hours later: morbilliform rash on neck, injection site, stomach, and back

103 degree fever, headache, fatigue, muscle and joint pain, injection site pain, chills, fever, and nausea. Developed symptoms starting at about noon the day after vaccination and progressively got worse throughout the afternoon and evening. Symptoms made it impossible to conduct normal activities but have mostly resolved in the second day.

?COVID arm? - red, painful, swollen, hot, itchy skin around injection site, about 3 inches in diameter. Painful to sleep on.

Pfizer-BioNTech COVID-19 Vaccine EUA Injection site pain tiredness headache stuffiness muscle pain, pain at base of head and top of neck, hip pain, knee pain chills fever (2 days at 100F) nausea dizziness itchiness

Sore throat starting the next day possibly connected to the high pollen count rash no itching just warm and red skin

I was 34 weeks at the time of vaccination. Initially, I only had pain at the injection site. I woke up the next day with diarrhea that lasted about 6 days. I had no other symptoms besides dehydration and back pain. On Day 3, I was instructed to take Imodium, which I took for about 2 days, but it didn't help. Around Day 5, I was given fluids, my urine was tested and multiple GI tests were run. I was placed on antibiotics for a UTI. PVCs were also discovered at visit, but it's not connected to the vaccine.

Patient described itching and rash on skin. She would scratch her skin and break out in hives where she scratched. The itching would intensify and then go away and move to a different area of her body. 80% of the itching is on her back, neck, shoulders, and legs. She shared that the injection site is unremarkable. At time of call, she was trying to get a hold of her health care provider.

Monday I received the vaccination (1st of the 2). Tuesday I started seeing bruises on my right side (I was vaccinated in my right arm). I can see 5 bruises. 1 on my right arm. 4 on my right thigh. All are various shapes (dime sized to quarter size) but they are all more of a darker yellowish bruise. I did test positive for Covid back in November 2020 and didn't need any medical treatment. I was told that 90 days out was okay for receiving the vaccination.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Rash Generalized-Medium

Stayed 30 minutes after vaccine at vaccination clinic to be safe in case of a reaction. About 5 minutes after leaving 11:30 I could taste the vaccine in my mouth. I immediately felt intense sharp tingling in my lower lip, it felt hot and swollen (upper lip never had a reaction). I instantly felt a lump in my throat and had a hard time swallowing. I started with chest pain that resolved itself in a minute or two. A few minutes later a family member noticed my face was red and flushed and said I looked like I had a sun burn. Swelling in throat resolved within an hour. Lip never visually looked swollen but I could feel the tightness, burning and tingling that resolved within the hour. Redness on face resolved within a couple hours. Had tiny blisters about 3 show up above upper lip I still have them the next day with a couple more but they aren't causing problems. My airway was never blocked I never had a hard time breathing. I did have a sore throat this morning March 25 day after vaccine. All other symptoms seem normal.

I developed a rash ten minutes after receiving the second dose. On my neck and it trailed down to chest area. They took me to Urgent Care and they gave me Benadryl and the Rash went away.

Fever, chills, body aches, muscle and joint pain, nausea, vomiting, diarrhea, trouble concentrating , headache. These symptoms lasted about 30 hours. Headache, trouble concentrating, pain at injection site have lasted almost 48 hours and continue to exist but have been reduced over time

Less than 3 minutes after administration, I began having tingling in my throat. My heart began to race. I grabbed a medically professional who assessed me, she stated I was beginning to flush and then had EMS respond. Vital signs indicated a peak heart rate in the 160?s, O2 Sats were in the 80?s. I also had a metallic taste in my mouth and a tightness in my airway. Later in my hour observation I had a period of facial flushing and itching. I had ice packs placed on my skin, given a fluid bolus and monitored by an RN and EMS personal. A Doctor assessed me and contemplated transporting to the ED for management but I was slowly feeling improvement. I was monitored for an hour and felt okay when I left the clinic.

Employee reports after second dose onset on chills, and soreness to injection site. sxs resolved on own. Employee reports having both Pfizer vaccines 1st dose 12/23/20, 2nd dose 1/12/21. Employee became symptomatic and tested Covid positive 3/25/21. BWH Infection contact tracing team has identified the employee as contracting Covid by a Community Contact. Employee quarantining at this time.

3/27: headache, fatigue 3/28: swollen lymph nodes, headache 3/29: itchy rash covering arms and legs with patchy areas on back and stomach; bottom lip swollen

Almost immediately after having the shot had feeling of tightness of the throat and some redness of the face. Refused an epipen shot but did take benadryl. Paramedics were called but did not go to the Emergency Room. At all times could breath, just a tightness of the throat. Continued to take benadryl until I fell asleep that night, still had tightness of throat until I went to sleep. Woke up with a slight sore throat and some pain at injection site.

Covid arm, minor. Directly around vaccination area for the past 9 days since getting the vaccine. Red, itchy, slightly raised

I got a headache 30 (around 2:45) minutes after the shot. I laid down when I got home and took an hour nap. Follow the nap, the headache was gone. My left arm in the spot of the injection was sore for the next couple of days.

Woke up with the injection site feeling very hot and painful. Pain level is worse than I typically experience with my fibromyalgia, as a point of comparison. Have been very tired all day and slept approximately 13 hours total from when I went to bed last night to when I finally got out of bed today. Heat is still present but has died down; pain and fatigue are about the same as when I woke up in the morning.

Red rash all over my body with hives that were itching uncontrollably. Anytime I was touch my body or a red rash/whelp would appear. I felt nauseated, had chest pain and felt fatigued. This occurred at all times of the day and night and was worse when I wore loose clothing.

Migraine; headache; visual impairments; pain at injection site; This is a spontaneous report from a contactable Other HCP (Patient). A 26-yearfemale patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EM9809) dose 1 administered in Arm Right on 04Feb2021 17:30 as single dose for covid-19 immunisation. Patient medical history contains allergies to Oats, sulfa containing antibiotics. Concomitant medications were not reported. It was reported that on 05Feb2021 12:30 PM patient experienced migraine and headache for 7 days (still ongoing) visual impairments and pain at injection site. The patient had taken migraine medication. On 08Feb2021 Patient undergone PCR test Covid test post vaccination through Nasal Swab shown a Negative Covid test result negative. On 11Feb2021 Patient undergone PCR test Covid test type post vaccination nasal Swab shown a negative Covid test result. The outcome of the event pain at injection site resolved in 1 day remaining events with outcome of not recovered. The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on [24Mar2021], this case now contains serious adverse reaction(s). Information processed together.

The day after the shot I had a headache all day, and a fever of 102 degrees that came and went throughout the day. My shoulder muscle was a bit sore at the injection site. Chills came and went throughout the day as well. Then the following day (Monday) I was completely fine.

101°F fever (began approximately at 9:00pm 04/02/2021; ongoing as of 4:32am 04/03/2021 ) Chills Muscle and joint pain Swollen lymph nodes in neck and armpit Fatigue Injection site pain Pain while using injected arm Headache Abnormally high thirst Difficulty sleeping

26 y/o F who presents to the ED with complaints of an allergic reaction to her 1st Pfizer COVID-19 vaccine that she received on 04/01/2021. Pt reports generalized urticaria with pruritis and an itchy throat. Pt says she does not have a history of reactions to vaccines. Pt denies SOB, lip edema or throat swelling. Pt says she has taken benadryl for her symptoms with some alleviation. Pfizer Vaccine Lot #: ER8733 EXP date: 07/31/2021.

Muscle aches localized to right upper extremity, shoulder and neck muscles; Significant tenderness to right deltoid (injection site); This is a spontaneous report from a non-contactable health care professional (other HCP; patient herself). A 26-year-old female patient received the second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE solution for injection; Batch/Lot Number: EL3248; Expiration date: Unknown) via an unspecified route of administration in the right arm on 28Jan2021 14:15 (at the age of 26-years-old) at a single dose for covid-19 immunization in a hospital. The patient's medical history and concomitant medications were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (Batch/Lot Number: EL1284; Expiration date: Unknown) via an unspecified route of administration in the right arm on 08Jan2021 10:00 (at the age of 25-years-old) at a single dose for covid-19 immunization. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has not been tested for COVID-19. The patient has no allergies to medications, food, or other products. On 30Jan2021 09:00, the patient experienced muscle aches localized to right upper extremity, shoulder and neck muscles and significant tenderness to right deltoid (injection site). Injection site was also reported as right arm. The events were reported as non-serious. No treatment was given for the events. The outcome of these events was recovering. No follow up attempts are possible. No further information is expected.

Approximately 25 minutes after vaccination the patient reported starting to feel itchy all over. 50 mg of Benadryl was administered to the patient. The patient was monitored for another 30 minutes to ensure the Benadryl was working. After the 30 additional minutes the patient reported feeling much better and left the store.

Pt came into the clinic, 4/2/2021, states that she received the Pfizer on 3/18/2021, she got a itchy red rash all over her body. Pt states the redness has gone away but her body is still itchy.

I developed a Severe rash (blotchy, red, itchy ) all over both arms and back 36 hours post 2nd dose Pfizer vaccine. I had a high fever of 103 and massive headache too and body aches

In 24 hours , had rashes/hives on face and neck which were itchy, also had slight wheezing . Contacted pharmacist who advised Benadryl and once I took it symptoms subsided.

Site: Pain at Injection Site-Severe, Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe

Increased reactions to existing allergies. The skin around my eyes became very inflamed and my skin has been non-stop itchy for 24 hrs. all over my body. My skin gets hives as well. I have never had allergic reactions like this in the past to any of my allergens. Normally, I would take Allegra and this would help my allergies (I have done this for years). Now even Allegra doesn't help anymore all of a sudden. My allergist told me to increase my dosage of Allegra and start taking Pepsid to help control the itching.

I got my first r my first dose of the pfizer vaccine dose at 9 am that morning and around 10 hours later around 8 pm I got hives on the left side of face and hives/ swelling around left eye and my nose was literally dripping mucous like a faucet onto the floor and I started getting a super itchy and tight through. Obviously an allergic reaction, I took two benedryls fell asleep and woke up fine. I am not sure if I should get my second dose tomorrow.

Immediately after the first shot, left arm was so sore it could not be moved or touched. 36 hours after the shot, a high grade fever developed, accompanied by shaking and intense muscle aches. Acetaminophen helped reduce symptoms, however sore arm persisted.

Patient is here today for COVID-19 immunization per federal guidelines/written order. See immunization activity for details. Patient was observed post-immunization for a minimum of 30 minutes due to previous history of immediate allergic reaction to a vaccine or injectable therapy and/or history of anaphylaxiswith evidence of throat tightness and itching. Anaphylaxis Management Standing Order protocol initiated. Physician/APP notified of patient condition. Additional orders received: per Doctor: Benadryl 50 mg IM x one. COVID-19 (MRNA) VACCINE Allergen added to patient's Allergies. VAERS reporting completed as appropriate. . 1400: At end of 30 minute observation period (due to hx of latex allergy), patient complained of itching on chest and throat with some 'tightness' in her throat. Patient escorted to exam room and met with RN and the doctor. 1405: Benadryl 50 mg IM given right deltoid per order of the doctor who examined and talked with patient. Will monitor additional 30 minutes post injection per MD order. 1412: BP 120/64, P 61, Pulse Ox 100% on room air. 1414: Patient states she can now swallow with ease. 1418: Patient states swallowing is good and itching is subsiding. 1425: Patient states feeling much better, just sleepy (spouse is driving her home). 1432: Redness on chest gone, patient states itching has resolved and throat is open. Breathing unlabored with no additional symptoms. Discharged ambulatory to meet husband downstairs who will drive her home. Per direction of Doctor, patient will premedicate with oral Benadryl prior to receiving 2nd COVID vaccine. Patient verbalizes understanding. COVID-19 post-vaccination Patient Instructions added to After Visit Summary for patient to review.

I was slightly overheated after shot but that lessened quickly. My arm hurt and was swollen the first time I got the covid shot but yesterday after the second shot it got really itchy and swollen. It is hard to lift my arm and started to worse throughout today. The injection site is a misshapen red rash that has spread. It started to leak a clearish pus liquid about an hour ago. I am recovering with a bandaid and adding antibiotics cream just in case. I will call my dr tomorrow if it continues to worsen.

Woke up around 2am after vaccine administration with a very sore arm. Pain went down to forearm and down shoulder and back muscles. Woke up again around 6:30 am with a low grade fever of 99.5 degree F. Took ibuprofen to help bring down the fever and help with the pain. Throughout the day experienced cycles of hot and cold flashes as well as pain around injection site and sharp pains down arm to my fingertips. Symptoms subsided by around 8pm the day after vaccination.

Less than five minutes of receiving vaccine: Eyes rolling back, feeling of fainting, tinnitus, blue lips, blue fingers, really hot, Thirty minutes after receiving the vaccine: bad chills/shakes/shivers/teeth chattering, diarrhea, confusion

I believe my vaccination was administered incorrectly and administered subcutaneously instead of the required intramuscular route as I have shooting tingling pains going down my arm since immediately after vaccination. The pain has slowly been getting worse and worse and after some research I am quite confident my vaccine was administered incorrectly based on the video I just watched on the CDC's websites showing how to administer Subcutaenous vaccines versus Intramuscular ones. The pharmacist exactly followed the video to administer my Pfizer Covid-19 Vaccine via the subcutaneous route and she squeezed my upper arm fat and injected me at a 45 degree angle. At the time, I remember thinking it was strange she did that as hsitorically I always had doctors vaccinate me and they NEVER squeezed my arm fat and always vaccinated me at 90 degress rather than 45 degrees. I am at a loss at what to do as I am confident the vaccine was NOT administered correctly and my fingers tingle uncontrollably and I also have weird bruising all over my hand and arm. Aside from the pain, was the vaccination even effective? Or am I suffering now for no reasons.

When I first got my shot I had a wave of heat go through me and then my throat and moth went dry. I waited my 15 minutes and get fine. 40 minutes after my shot I developed swollen face, lip, tongue and throat numbness and get like I couldn?t breathe. Then I went to ED. They gave me Benadryl and steroid and eventually sent home. Today 04/10/21 I woke up. Took my Benadryl and prednisone and about and hour after that my face has been extremely red, numb, and burning. It?s been 9 hours and I?m still having these symptoms. Called ED they said to stop the prednisone and only take Benadryl but my face is still really hot, red and burning.

tightness in chest and throat, itching in chest, flushing, tachycardia, febrile. Shaking, facial itching.

Pfizer dose one vaccine given at 9:50 AM, went over for observation before leaving and started having symptoms at 10:20 AM. Symptoms were throat tightness, flushed skin, numb/tingly feeling on face and chest, rash/hives, itchiness. I was given 50 mg Benadryl via shot in right arm. Symptoms worsened and I was taken to the emergency department at the hospital. I was given zofran via IV, steroids via oral pill, and monitored. Symptoms started to get better and I was discharged around 1:30 PM.

Patient reports hives after receiving first vaccination. Started on hand and "moved up [her] arm". No shortness of breath. Did not take any meds to help with the hives. Hives are still present today (4/10/2021), but are improving. Did not report ADE to physician or healthcare provider. Hives were mentioned during check-in at which time VAERS report was filled out.

Left arm sore at injection site Left eye and cheek swelling, redness, and heat Fever of 99.6 degrees Started around 9:00pm on 04/03/2021

Patient complained of redness, swelling at itching at injection site at the end of her 30 minute waiting period. The provider on call was contacted and the patient was given 25mg of PO Benadryl and observed for an additional 30 minutes. Symptoms resolved and she was able to leave the clinic after her 2nd 30 minute wait.

Welts on the back of tongue. Swollen papillae. Blister sized lumps. Painless but seem to be increasing in size

Noticed rash in inner elbow on right arm approx 27 hours post-injection. Red welt approximately penny sized. Not itchy. Spread to right wrist and neck 39 hours post-injection. Subsequent spots were clusters of tiny red spots (ball point pen size). Spread to chest, right thigh (welt quarter sixes), right leg, and right foot 50 hours post-injection. Mild rash on inner left arm at 50 hours, no clusters just single dots all over arm.

Sore injection site after vaccine; no other symptoms same-day. The morning after (04/12), woke up with chills, body aches, skin very sensitive to pressure, minor brain fog, minor body weakness. Possibly a fever overnight.

Hives on left arm 4:40 p.m. Disappeared by 9 p.m. Abdominal cramping (severe) and bloating noticed Sunday, 4/04/2021, roughly 8 a.m. Symptoms consistent with allergic reaction to red meat (alpha gal syndrome).

pt felt dizzy and had a red face, no vasovagal symptoms, anxiety reaction resolve, VS AT 12:49 170/103 P 79 02 97 VS AT 12:54 BP 155/87 P 70 02 98 VS AT 12:59 BP 156/91 P74 02 98 VS SITTING 1301 BP 164/109 P 76 02 96 VS STANDING BP161/92 P 82 02 97; PT WAS GIVEN WATER AND WAS ESCORTED BY STAFF TO GO HOME

The patient is a 26 year old female who presents to the practice today for a transition into care.The patient is transitioning into care from an emergency room and a summary of care was reviewed. Note for "Transition into care": Patient went to ER 4/9/21 for facial swelling, numbness and feeling like she could not breath and was discharged 4/9/21. Patient states she had the covid vaccine Pfizer 4/9/21 and had reaction after about 40 minutes. Patient states the right side of face started to swell, numbness across her face (lips, tongue, throat) and she felt like she could not breath. Patient was given Benadryl, Pepcid and Decadron. Patient was prescribed for Benadryl and Prednisone. Patient states on 4/10/21 she had a reaction to Prednisone with beet red face, facial warmth, rash, and facial numbness again. Patient states when getting the Hep A vaccine 3/17/21 she felt a wave of heat go over her body and her mouth and throat were super dry and the same thing happened when she got the Pfizer covid vaccine.

I have had a low grade fever, chills, fatigue, and body aches for two weeks now (on going as of 4/13) fever spiked and I broke out in hives the night of 4/12

I am reporting an incorrect injection of the Pfizer COVID vaccine. I received my first dose subcutaneously at a 45 degree angle rather than intramuscular as recommended. I have video evidence showing the improper injection. I brought this to the attention of the office manager at the location I received the vaccine who spoke with their head doctor and I was advised that they will not be reporting the incident. I currently have a red mark near the injection site that is approximately the size of a half dollar that is slightly swollen and feels ?hard.? I also have a sore arm, slight headache, and fatigue. I am concerned about potential side effects from the improper subcutaneous injection as well as the efficacy of my 1st dose. Also, I am concerned with how many others have been injected this way at this establishment by this tech, and hope that actions will be taken to make sure this doesn?t continue to happen there.

12 hours after vaccine, fever and chills began (peaked at 103.2 degrees), unable to move from bed. Fever broke around 12 hours after beginning. 24 hours after vaccine, bruising below injection site and swollen lymph node under arm (still persisting 3 days later). Continued headache and tiredness.

Delayed hypersensitivity reaction: erythematous rash of left deltoid/injection site starting on day 8 (4/15/21)

RED RASH FROM ELBOW TO HAND ON RIGHT ARM, RASH ON INSIDE OF ARM/ELBO ON LEFT ARM, ITCHING ALL OVER. GAVE PATIENT HYDROCORTIOSONE 1% TO APPLY ON ARM, REDNESS WAS BETTER BUT ITCHING WAS WORSE, GAVE EPI-PEN, PATIENT BOUGHT BENADRYL TO TAKE AT HOME

After receiving first COVID vaccine patient reported tasting metal, itchiness in right leg. Patient was monitored for an additional 10 minutes, no additional symptoms were noted during while being monitored.

I was given my second shot yesterday and at first I had a mild headache and then it got worse and I was very tired. My arm was sore and I could not lift it. Waking up this morning and my chest hurts and is getting tight. I have a bad headache. And I am very irritable. My arm at the injection site still hurts a bit.

Red spots on torso in various locations and various sizes. Slightly raised but not irritated or itchy. Slightly sensitive and can become irritated after exercise or warm shower. Continuous development of spots, initial spots growing in size. Abnormal and oval shapes.

she started noticing on 4/17 new onset of numbness and as though her left arm at the injection site feels "heavy and weighed down". stated her pain level is moderate with a scale of 5 out of 10. she hasn't taken any medications to treat and is pending seeing her PCP.

Fever, chills, headache, body ache, swollen lymph node on left arm, redness and swelling on injection site

The day after the vaccine I woke up with a red, raised, warm, itchy circular rash on my arm at the injection site. It was about 2 inches by 2 inches. It is currently 3 days after my vaccine and I still have it. I am 7 weeks pregnant with EDD of 12/1/21.

Vaccine Adverse Event (make sure DOB, age, health conditions/allergies, and current medications coded on front screen). 26 year old female received the 2nd dose of the Pfizer COVID-19 vaccine at the Convention Center on 04/08/2021 @ 08:00. Pt started experiencing a fever on 04/09/2021, highest temp recorded was 102.9F now 98.9F, but temp goes up to 101F in the evening when sleeping. On 04/10/2021 pt started experiencing hives (red, raised, itchy patches) on both sides of the hips and the upper right arm (opposite arm in which the vaccine was administered). Pt is allergic to penicillin and amoxicillin. Pt took cetirizine before calling. Pt takes Metformin 750mg and has polycystic ovary syndrome. Pt was advised to go to the ER in case this could be an allergic hives reaction. SPI was consulted and Dr. was notified.

Itchy rash on her chest a day after her first dose on 3-22-2021. Worse rash on her chest and lower back (small red rash with some raised wheal) after the second vaccine on 4-14-21.

I noticed hives all across my torso/back about 6 hours after the vaccine. They wasn't terrible hives, but they were definitely there and a bit itchy. Hives stayed for two or three days.

Initially experienced high fever, muscle, and joint pain from head to knee on the side of the body that was vaccinated. Later developed hard, warm bump around injection site which has mostly subsided. 4 days after the shot I started experiencing intense headaches and dizziness, plus sensitivity to light.

Client expressed that on 4/19/2021 at 1:50 pm, received the Pfizer COVID 19 vaccine in left arm. Per Client has soreness at injection site and in Deltoid muscle area on going. On 4/21/2021 Client reports, on the left arm and hip developed a red, itchy, patchy, raised rash and applied Benadryl Gel to sites, with some improvement. Per Client, that evening on 4/21/2021, developed a new rash on right arm and right neck, so Client took antihistamine and applied Benadryl Gel to both sites. Per Client, took Ibuprofen and Tylenol for soreness in arms. Per Client no follow up with PCP for symptoms and still having mild symptoms. PHN suggested that Client follow up with PCP, continue to monitor symtoms and go to Urgent Care,

Beginning approx. 3am 4/20/21 - fever, chills, muscle aches, nausea/vomiting. Fever, chills, muscle aches continued through 4/21/21. Rash on torso began 4/21/21.

Patient C/O itching to face and then stated that her throat felt itchy. Gave EpiPen to Left thigh. Patient stated that she felt the itching subside and throat felt fine withing 5 minutes. HR 111 BP 128/80 Ox Sat 100 throughout No wheezing, SOB, Stridor or visible scratching of face. Patient released to EMS

On the 3rd day of the vacation I began to present an allergy that began in my neck and spread throughout my body, at first it only turned red but later at night it began to get much more rash and hives.

At 9:00 PM on the day of vaccination (8 hours after vaccination) I felt achy and tired and needed to lay down. I also had chills and soreness & swelling at the injection site. I went to bed at 10:30pm. At 1:45 AM (13 hours after vaccination) I woke up with low grade fever, chills, muscle/body aches, fatigue, headache, earache, and sore throat. I could not go back to sleep all night and by 3:00 AM (14 hours after vaccination) I also had nausea and light, dry cough. I had sharp headache and earache pangs. These symptoms persisted. At 11:00 AM the following day (22 hours after vaccination) I took Nyquil containing acetominophen. At around 4:00 AM the next night (39 hours after vaccination) my fever was gone and the other symptoms started to slowly get better the following day.

No major side effects with FIRST dose, only sore arm at injection site for about 12 hours. Second dose has resulted in severe swelling at injection site. Pain was comparable to the first dose until about 12 hours later. Before bed I took one standard strength ibuprofen and drank plenty of fluids, with more at my nightstand. Woke up several times throughout the night due to arm pain. The following morning woke up with severe arm pain and swelling, nausea, fatigue, extreme thirst, and chills. No fever. Shoulder region at injection site was red and warm to the touch, with the swollen region about 3.5 inches in diameter. Arm pain continues but is not hindering movement or normal activities. Swollen region has not decreased in size and remains red, warm to touch.

pt says she has blue circle around the injection area that it is lumpy and has been there about 5 days.

The patient contacted public health, via interpreter, approximately 30 min after vaccination to report a rash started on her face and has now spread to her trunk and arms. Rash was reported as red and very itchy. The client returned to the clinic approximately 3 hours after vaccination and received a dose of diphenhydramine and written instructions on continued use. We then consulted with Dr., volunteer advisor to Public Health COVID Vaccine clinics. Dr spoke with the client and then submitted this situation to Dr., with the following information: "a 26 yo woman without any prior hx/o of allergy or atopy developed a pruitic rash 30 minutes after

Hives broke out around an hour and a half after vaccine. Only on abdomen and lower back. When woke up the next morning, they were gone.

Client was vaccinated around 1710, fainted at 1715 and hit posterior aspect of her head. One small approximately 1cm laceration present on posterior head. Client placed supine, BP at 1716 was 100/64, improved to 110/78 after 5 minutes. Advised client and mother to go to the ER but refused due to lack of insurance. approximately 1730 client felt nauseous and 911 was called and client was transported to the hospital.

Chills and low grade fever began at 8:00 pm ~ 12 hours after 2nd dose. Also experienced headache, muscle and joint pain, injection site pain, and nausea. On 4/25 experienced low grade fever in the morning, nausea, headache, tiredness, and feeling unwell throughout the day.

About an hour after I looked in the mirror and saw that my entire right cheeck was bright red, hot, and itchy; About an hour after I looked in the mirror and saw that my entire right cheeck was bright red, hot, and itchy; About an hour after I looked in the mirror and saw that my entire right cheeck was bright red, hot, and itchy; My throat was also just a little bit tight and breathing was labored/Little tightness around the throat; My throat was also just a little bit tight and breathing was labored; allergic reaction; rash all over my face; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm at the age of 26-year-old on 07Apr2021 14:40 (Lot Number: 7131121) as single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Medical history included lung transplant from 2016 (recipient of double lung transplant in 2016), Slight damage to the windpipe, Asthma, immunocompromised. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included prednisone; metoprolol; magnesium chloride. The patient previously took cefdinir (OMNICEF) and experienced drug allergy, clarithromycin (BIAXIN) and experienced drug allergy. Patient got her shot at 2:40 pm. Seemed fine, waited at the star for 15 minutes and went on her way. About an hour after patient looked in the mirror and saw that her entire right cheeck was bright red, hot, and itchy on 07Apr2021 15:30. Her throat was also just a little bit tight and breathing was labored on 07Apr2021 15:30. Patient went to the emergency room and was given 25mg of oral Benadryl, 20mg of famotidine, and a dexamethasone shot. Patient was then observed and released once her reaction started to calm down. Consumer stated, she was calling because she had a allergic reaction to her first dose of the Pfizer Vaccine yesterday (07Apr2021). It did occur just after half an hour of the Vaccine on 07Apr2021 15:10. She broke out in a rash all over her face in Apr2021. Little tightness around the throat. Therapeutic measures were taken as a result of 'about an hour after I looked in the mirror and saw that my entire right cheeck was bright red, hot, and itchy, 'my throat was also just a little bit tight and breathing was labored/little tightness around the throat', 'my throat was also just a little bit tight and breathing was labored'. Adverse events 'about an hour after I looked in the mirror and saw that my entire right cheeck was bright red, hot, and itchy, 'my throat was also just a little bit tight and breathing was labored/little tightness around the throat', 'my throat was also just a little bit tight and breathing was labored' result in Emergency room/department or urgent care. The outcome of events rash all over my face and allergic reaction was unknown. The outcome of other events was recovered in Apr2021. No follow-up attempts are possible. No further information is expected.

Sore arm around injection site; tired; This is a spontaneous report from a contactable pharmacist. A 26-years-old female patient received second dose of (BNT162B2) (COVID-19 Pfizer vaccine), via intramuscular route, administered in right arm on 10Apr2021 16:00 (Lot Number: EP6955) as single dose for COVID-19 immunization. The patient's medical history was not reported. The patient did not have any allergies to medications, food, or other products. Concomitant medication included Loratadine, Birth control pill and Multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had previously received the first dose of (BNT162B2) (COVID-19 Pfizer vaccine), via intramuscular route, administered in right arm on 20Mar2021 16:00 (Lot Number: EP6955) as single dose for COVID-19 immunization. On 10Apr2021 at 22:00, the patient experienced sore arm around injection site and tired. As a therapeutic measures included Tylenol, apply ice to site, and nap were taken. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient has not been tested for COVID-19. The outcome was recovering for both the events at the time of reporting. No follow-up attempts are needed. No further information is expected.

Nausea, vomiting, headache, severe dizziness, mild swelling everywhere, moderate swelling at vaccination site, back pain, aches, chills, pain at vaccination site. Time: 5 days.

Left arm numbness and pain post injection, post 2nd Pfizer injection. Felt very tired and fatigue. No chest pain or SOB or cough or rash or edema. Was given Loratadine 10 mg x 1 by another health-care provider at the clinic. Felt Fine Saturday April 24/2021. On Sunday April 25/2021, really tired and fatigue still. Did report a fever of 102 F on Sunday evening.

TWO DAYS AFTER THE DOSE ON 04/07/2021 IN THE EVEN9ING SHE DEVELOPED A MINOR RASH ON CHIN, JAW AREA AND CHEST . THERE WERE LARGE PAINFU;L RAISED BUMPS AND FELT LIKE SUNBURN. THERE WAS FLUID BUILD UP UNDER THE JAW AND CHIN AREA.

I received my second dose of Pfizer around 3pm on Sunday, April 4 2021. By about midnight, I had a fever and the fever/headache and exhaustion persisted throughout Monday. I did not take any medicine. By Tuesday morning, my fever broke, but I developed a large 6 inch rash under my left armpit (my second shot was in my right arm as I am left handed). By Tuesday afternoon, I had developed a bad cough. Given that I work remotely, and had only been to a grocery store (double masked) with my mother a few days prior to the second dose, I assumed the cough was a result of the second dose. My cough become worse, and by Wednesday it sounded like bronchitis so I went to my doctor. She believed that it was a bronchitis cough, had me tested for viral infections, and put me on a variety of medications from antibiotics to steroids and inhalers. I tested negative for all the respiratory illnesses I was tested for, as well as COVID-19. The medications did not seem to help, and my doctor added another inhaler and medication to the mix. After about 2 weeks of medications and no improvements, my doctor had me get a chest X-ray to make sure I didn?t have pneumonia or any other obstruction in my lungs. I also stopped all medication on Tuesday, April 20. My chest X-ray came back clear later that week, and I decided to just stay off all medications and hope that my body would self heal, since this seemed to be a self created bronchitis, as my parents did not get sick. Finally, after 2 weeks and 4 days, my cough has improved significantly to the point where I can now talk almost normally, without going into coughing spasms and feeling as though it was difficult to breathe.

1-2 minutes after injection had a metallic taste in mouth. Noticed about 5 min after injection noticed numbness in my left injection arm that spread through all my limbs. Alerted personnel- I became light headed and let them know i was about to faint. Blood pressure raised and heart rate increased rapidly. A rash appeared on my neck and white welts on my face. Was rushed to ER and administered Benadryl, Pepcid, and Prednisone. Confusion and trouble speaking following event. Continued confusion and headache

I noticed some singular tiny itchy spots on random spots on my body (arm, leg, thigh, back) that looked like tiny hives. They would have itchy periods then not bother me, but I could still see them as little raised bumps. Sometimes they would become larger like the size of a mosquito bite. (I was inside and not near any bugs). They would reoccur at least once a day every day (almost 2 weeks now). Occasionally when I scratch an area the hives will get bigger and blotchy. In two spots I got little purple bruise dots from scratching. I?ve been using topical Benadryl and it helps temporarily.

Severe headache, sinus congestion, dizziness, nausea, diarrhea, heavy menstrual period, fatigue, drowsy, muscle pain, injection site soreness

Fever up to 103, rigors, intense myalgias, lymphadenopathy/lymphadenitis, sharp pains in feet, injection site pain, headache, vomiting lasting for 3 days. Still (4 months later) getting lymph node sharp pains frequently

Shingles - I caught it pretty early. The nerve pain began Saturday afternoon and continued through Sunday. Monday morning after the rash started, I scheduled an appointment with the Health Center and they were able to see me that day. I was quickly diagnosed with shingles. It was located on a band on my left chest, neck, shoulder, and back of my ear. The nerve pain lasted almost 3 weeks. The rash has mostly faded by now (4/27). I was given 7 days of Valacyclovir to treat.

It?s been a week after my second dose. I?m having an extended menstrual cycle since the 12th of April. After the second dose it?s extended my period and made it extremely heavy, having lots of clots in my cycle, still having tingling and numbness in my right forearm, tingling/ itching in my ears, very tired all day. The main concern is that with the vaccine I?m of day 17 of my period and it doesn?t seem to be slowing down just getting heavier.

Red rash on left upper arm under site of injection starting in morning (8AM wake up), lasting no longer than 8 PM.

Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: foggy headed-Medium

Headache, pain and soreness at injection site that makes it difficult to move left arm, joint pain in hips and knees, fatigue, overall abdominal pain

10 minutes after shot throat was itchy, 30 minutes after shot throat was more itchy and broke out in hives across chest and outside of throat

Patient received first dose of Pfizer vaccine and was waiting in the observation area when she fainted, fell from the chair, and hit her head. Patient was awakened with the ammonia inhalant. Patient tried to sit up and fainted a second time. Patient was assessed by an RN. Patient began to develop a hematoma to the left side of the forehead and some bruising to the left side of the face. Patient refused EMS and called her father to pick her up. Patient stated that feeling dizzy and fainting was a common occurrence after she received injections. Patient?s father arrived at 1500. Patient continued to refuse EMS, but both patient and her father were strongly advised to go to the ED to have her assessed further. Patient was helped to wheelchair and accompanied by security and RN to the car at 1507.

Injection site soreness - ongoing but not as bad as first dose Fatigue, light nausea, and elevated body temperature (fluctuating in the 99 F range) - on day of vaccine and following day. Took 1 Tylenol on the first night to help with reducing headache and arm soreness for better sleep.

rash all over her upper body: her belly, some on her back, and mostly on her neck and shoulders; rash has worsened in redness/rash is red; a little bit of difficulty of breathing; feels shaky/nervousness/she is nervous; This is a spontaneous report from contactable consumer (patient). A 26-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Apr2021 at 15:00 (lot number: EW0162) on the left arm as single dose for COVID-19 immunization. Medical history was reported as none. Concomitant medication included paracetamol (TYLENOL). The patient next dose was scheduled for 03May2021 at 11:40am. On 14Apr2021, patient reported to have a rash all over her upper body: her belly, some on her back, and mostly on her neck and shoulders. Patient mentioned she had a very severe rash all over her body and neck that it was pretty extreme and all over. It was the first time that something that extreme happened to her. Patient mentioned that she also had a little bit of difficulty of breathing and attributed it to her nervousness. She denied having a closing up throat. The rash all over body was reported as worsened and rash had worsened in redness. The patient's rash was red, patchy, and on her stomach it was more needle point looking. The patient wasn't feeling sick and didn't have any of the other symptoms. The patient felt shaky but it may be because she was nervous. The outcome of events "a little bit of difficulty of breathing" and "rash has worsened in redness/rash is red" was unknown, while the other events was not recovered. No follow-up attempts are needed. No further information is expected.

Pfizer-BioNTech COVID-19 Vaccine EUA from 10 am Friday, April 30: Fever, headache from 4 pm Friday, April 30: Upper back pain (in one particular spot) spreading out to chest and teeth from 8 am Saturday, May 1: Skin rash on neck and chest

Extreme soreness first 3 days after shot. Numbness of entire left arm. Tingling if moved too much. Pain faded by monday april 26th Discomfort returned to left arm Wednesday, april 28th. Thought I slept funny on it. Discomfort intensified Thursday, april 29th. Dull and constant ache of left arm. Numbness returns. Feels like deep tissue ache. Stretched out arm thinking it would help. Caused tingling and numbness. Left underarm hurting. Slept most of the day. Discomfort worse Friday, april 30. Unable to sleep. Arm feverish near injection site. Not feverish myself (37.1 c). Aches worse. Stretching and trying to work out aching. Unable to. Swollen lymph node gland under left arm. Ache spreading to lymph node in neck. Took ibuprofen, it helped a little. Still unable to sleep despite ache somewhat lessening. Ache decreased as day went on. Saturday, may 1st. Ache still there as is swollen lymph node. Neck lymph node not swollen. Red feverish patch near injection site. Sunday, may 2nd. Just woke up from nap. Still swollen achy lymph node under left arm.

I originally had injection site pain immediately after vaccine, which went away after a few days. However, this week i began to feel injection site pain again that was dull, but still strange to me. I?m not sure if this is anything of concern, but couldn?t find instances online of this happening to anyone else.

After receiving 1st vaccine shot of Pfizer, patient developed mild generalized itching, feeling hot and red patches on left arm. Benadryl 25 mg was given orally. After several minutes, she was feeling fine. Er precautions given.

Reports she developed hives and wheezing same day (initially said within 4 hours, then shared it might have been within 7 hours) as her 1st COVID vaccine Pfizer dose. She reports calling her allergist and was recommended to take benadryl 50 mg po. She reports her symptoms improved so she did not go to seek emergency care. She reports numerous food and environmental allergies.

Pt received second dose of pfizer vaccine. 15 min later Pt states she began feeling itchiness on her bilat hands and arms, with redness and minor swelling. She also become to get shaky. She stated she didn't eat yet today. Pt received water and graham crackers and vital signs taken. Rash and itchiness began to worsen on arms and now neck rash and redness on bilat eyelids. Pt received PO benadryl 25mg. Pt called friend to pick her up prior to receiving the medication. Pt friend states she 50 min away. Pt states feeling better after taking benadryl. Rash and redness started to subside. Pt states feeling better and is able to walk to friends car . Pts vital wnl, itchiness and rash subsided. Stated to Pt if feeling gets worse or any signs of anaphylaxis to go to local ER and follow up with PCP. Pt verbalized understanding. Pt sent home with friend. VS: 8:30 HR 93, Resp 20, BP 120/70 O2 95% 8:40 HR 113, Resp 20, BP 137/84, O2 95% 9:15 HR 96, Resp 20 BP 122/76, O2 96%

2/4: Sore at injection site on R arm + mild dizziness & nausea. 2/5: R arm became very painful from shoulder to elbow, continued mild dizziness. Took Aleve & Advil didn't help. Pain continued all day. NOTE: Comorbid Congenital Myopathy (excessive muscle reactions to trauma), but no prior adverse reactions to vaccines or shots, incl allergy, XoLair, & Pneumovax23. Concerns about effect of Pfizer Vaccine on heart & lungs due to Congenital Myopathy, Dysautonomia, & chronic reduced lung capacity (60%). 2/6: R arm pain less intense, but expanded from shoulder to wrist. 2/7: R arm pain less intense, but now it affects whole R arm & fingers are numb. 2/8: same as 2/7.

Exactly a week after receiving the shot, a bright red welt appeared on the injection site. It was hot to the touch, hard, tender, and was itchy if scratched. It stayed hard, tender, bright red, and hot to the touch for three days before disappearing on its own. Having taken the second shot over a week ago, the welt hasn't reappeared. If you want to reach out to me, I have photographs.

Patient given Pfizer vaccine. Twenty minutes later she developed single hive to left neck. No other symptoms. Hx of allergies. Vitals and exam normal. She was given oral diphenhydramine x1. She waited an additional 30 min and then was accompanied home by her significant other.

pain and tenderness at the injection site; This is a spontaneous report from a contactable other HCP (patient). A 26-years-old female patient received BNT162B2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 05Jan2021 14:15 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included autoimmune thyroiditis, appendicectomy, pyelonephritis from an unknown date and unknown if ongoing. Concomitant medication included methimazole, atenolol, valaciclovir hydrochloride, ethinylestradiol, norgestimate (NORGESTIMATE & ETHINYL ESTRADIOL) and magnesium taken for an unspecified indication. The patient previously took azithromycin and experienced drug hypersensitivity. The patient experienced pain and tenderness at the injection site on an unspecified date. The action taken in response to the event for bnt162b2 was not applicable. The outcome of event was unknown. Information about lot/batch number has been requested. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

I had a couple of bruises to pop up but I didn't known if I hit my leg on something or not. Still this is the longest I've ever had bruises to last on my leg. It feels over worked. Also, my body feels shaky sometimes. I'm not sure if it's my nerves since I just lost someone close to me or from this shot. I've never felt shaky at random like this. It feels like my heart races when that occurs, too. It never last long, either.

About 18 hours following the injection (Tues), I got common symptoms (body and head ache, fatigue, but no fever). The following day all of those symptoms were gone, but my arm/shoulder where I got the injection had become swollen and developed a rash along my bicep. My lymph nodes in my left armpit were extremely swollen, painful, and tender to the touch. The rash and swelling went down within 24 hours (still there but significantly less) but the lymph nodes are still very large and painful.

Shortness of breath; Weakness; Fatigue; palpitations; Myalgias at injection site; This is a spontaneous report from a contactable Other healthcare professional, the patient. A 26-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: EL1283), via an unspecified route of administration on 20Jan2021 at left arm as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9231) on 30Dec2020 11:13 pm and experienced myalgias, diffuse, causal relationship was reported as related; on 31Dec2020 16:33 experienced fatigue and causal Relationship was reported as unknown; On 31Dec2020 16:33 experienced weakness and causal Relationship was reported as unknown; and on 31Dec2020 16:33 experienced sore throat and causal Relationship was reported as unknown. The patient was not admitted to hospital. One second dose the patient experienced weakness, fatigue, palpitations, and shortness of breath on 22Jan2021 and myalgias at injection site on an unknown date in Jan2021. The outcome of the events was unknown.

About a week after my second dose I noticed a rash developing on my left hand. My hand had become swollen the day after the vaccine. But had returned to normal until the rash developed. The rash was scaling and red, located on my left hand near my thumb and index finger. The rash appeared a week or so later on my right hand knuckles, also scaly and reddish. Kind of dry and very mildly itchy. The rash persisted about a month before it began to improve. I still have a slight rash that is now just faintly red/pink.

1st pregnancy, 32 weeks and 1 day, due July 1, 2021 adverse reaction: hives (small, itchy, red bumps) on inside of both arms from just pass the wrists to the middle of biceps

Uncontrollable chills; body aches; lower and frontal headache; upper back pain; neck pain; hives on legs; This is a spontaneous report received from a non-contactable other hcp. A 26-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN5318), intramuscular on 28Jan2021 as single dose for COVID-19 immunization. Medical history included COVID-19 from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. The patient did not have any known allergy. Post vaccination, the patient not tested for COVID. On 28Jan2021, patient experienced uncontrollable chills, body aches, lower and frontal headache, upper back pain, neck pain and hives on legs. It was unknown if the patient received any treatment for AE. The symptoms lasted for 2-3 days and approximately on an unknown date in 2021, patient recovered from all events. No follow up attempts are possible. Information about Lot/batch number cannot be obtained.

Really achy; her armpit in the same armpit is super swollen; nauseous; Armpit sore; Her arm where she had the shot is really sore; This is a spontaneous report from a contactable consumer (Patient herself). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number:EN5318, Batch number: Unknown. Expiration date:31May2021) via unspecified route of administration on an right arm on 21Apr2021 at SINGLE DOSE for COVID-19 Immunization. The patients medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN5318 Batch number: Unknown. Expiration date:31May2021) via unspecified route of administration on an right arm on 01Apr2021 at SINGLE DOSE for COVID-19 Immunization. Patient had her second dose of the Covid vaccine yesterday at 10:00. This morning, she woke up and she was really achy. Her arm where she had the shot is really sore, as well as her armpit in the same arm is super swollen. She is really nauseous today. She is mostly concerned about how swollen her armpit Treatment: She took Tylenol. The outcome of the event Arm where she had the shot is really sore was not recovered and outcome of all other events was recovering. No follow-up attempts are possible. No further information is expected.

Intense fever and chills 24 hours after second vaccine dose given. Woke up this morning (05/13/2021) with non-itchy rash all over torso, specifically under both breasts and scrawled towards back, around navel, and around crotch area. Splotches are an angry red but neither itchy nor warm to the touch.

Hives within inches of injection site after 24 hours. Headache and rapid heartbeat within 10 hours. Sharp and dull muscle spasms and tightness. Soreness in the injection arm.

Pain in right arm at injection spot, more than just feeling of soreness, 3 hours after injection. Nausea 12 hours after shot, vomiting 15 hours after shot, headache started at 6 am day after shot (or 17 hours after shot). Headache continued for 29 hours - advil and tylenol not effective at getting rid of pain. Nausea still continuing 48 hours after shot. Sweating 14 hours after shot and continuing for 12 hours - could be due to fever (was not able to check temperature but was feeling warm)

Worsened dizziness (up to 3 days after each shot,) Muscle pain (3-5 days after each shot,) Worsening of weakness (persisting still,) All over body itching - especially of the face (1-3 days after each shot,) Hives of the face (day of each shot,) Severe- but temporary- burning / nerve pain in the feet (few hours the night after first shot only,) Worsening of exhaustion (persisting still,) Signs of hormonal imbalance (persisting still- lab testing to follow,) Cold sweats / chills (1-3 weeks after each shot,) Nausea (persisting still {pt never had nausea before, and this has been the worst / most pervasive side effect},) Brain fog (1-3 weeks after each shot) Pain at injection site (1-3 days after each shot,) Vivid nightmares (1-3 nights after each shot,) Swollen lymph nodes (persisting still,) Sore throat (1-3 days after each shot.)

A rash that spread from my stomach to back, shoulders, neck, arms and legs; This is a spontaneous report from a contactable Other HCP (patient). A 26-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EL8982, Expiration Date: unknown) via an unspecified route of administration in left arm on 01Feb2021 (at the age 26 years) as 1st dose, single for COVID-19 immunization. Medical history included COVID prior vaccination and allergy to animal (cats). The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks. On 03Feb2021, the patient experienced a rash that spread from stomach to back, shoulders, neck, arms and legs. AE resulted in doctor or other healthcare professional office/clinic visit. Patient visited Dermatology, topical steroid and allergy med were given a treatment for the event. The patient was not tested for COVID-19 post vaccination. The outcome of the event was recovering. Follow-up (12MAY2021): Follow-up attempts completed. No further information expected.

swelling; pain at the injection site; it feels warm and it is "a little red"; it feels warm and it is "a little red"; This is a spontaneous report received from a contactable Other HCP. This 26-year-old female Other HCP reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Feb2021 (at the age of 26-year-old) as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received her first dose of the Pfizer COVID-19 vaccine on Saturday, 13Feb2021. The patient reported that, on an unspecified date she experienced pain at the injection site, swelling, and it feels warm and it was "a little red." The patient wanted to know that these side effects were common after receiving the Pfizer COVID-19 vaccine. The clinical outcome of the events was unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.

Got the injection On Friday. Saturday around lunch I took a shower and both my upper arms and across my upper back was a bad rash that itched and burned. An hour later, the rash faded away. Saturday I woke up sick with my hear hurting a stuffy nose that has gradually increased my symptoms and here it is a month later and I'm still sick.

SEVERE inflammation/tendinitis/crepitus/joint pain of 5th digit/pinky finger of right hand. Previously injured/tendinitis about a year earlier. GP doctor thinks I had a COVID vaccine-related autoimmune response that attacked a previously injured site. Symptoms started after 2nd dose of Pfizer COVID vaccine. 1st dose on 1/01/2021 (batch EK-9231), administered at. 2nd dose on 1/23/2021 (batch EL-9262) administered at. Treated with physical therapy, ice, heat, NSAIDs. Approximately 80% resolved as of mid-May 2021.

On the second day after the vaccine, I had swollen, painful gums. My gums bled off and on all day (5/14/2021, vaccine was 5/12/2021). On 5/15/2021 the bleeding gums stopped but the swollen gums continued through 5/18/2021. Other than that, I had typical side effects: pain near the injection site, fatigue, extremely swollen and painful lymph nodes.

Sharp left-sided chest pain 3-5 hours after injection, felt on "full breaths," felt similar to a pulled muscle, on the same side as my cardiac pacemaker- subsided after 24 hours Fever of 100-101 degrees F beginning within 2 hours of injection, intense and severe body aches and chills for 24 hours, nausea and upset stomach for 24 hours, Extreme fatigue for 24 hours - moderate for the next 5-7 days Arm swollen and stiff at injection site (despite heavy arm movement while in 15 min. waiting area) Mild dizziness and lightheadedness for first 5 minutes immediately after injection Severe headache for 48-72 hours

Vomiting; Paraesthesia foot; Bed ridden; Unable to walk; Vaccination site pain; This is a spontaneous report from a contactable physician. A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular on 26Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for rheumatoid arthritis.The patient medical history was not reported. The patient's concomitant medications were not reported. On 29Mar2021, patient experienced unable to walk with outcome of recovering , vaccination site pain with outcome of recovering , vomiting on 30Mar2021 with outcome of unknown , paraesthesia foot on 29Mar2021 with outcome of recovering , bed ridden on 29Mar2021 with outcome of unknown. The action taken in response to the event(s) for bnt162b2 was not applicable , for adalimumab was unknown. No follow up attempts are needed. No further information is expected.

Strong headache after shot, constant headache during the day of the shot; Pain on the arm where the shot was given; Tiredness; Weakness; This is a spontaneous report from a contactable consumer(patient). A 26-years-old female patient (not pregnant at the time of vaccination) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9262), dose 1 via an unspecified route of administration, in left arm on 11Feb2021 17:15 (at 26-years age) as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Facility where COVID-19 vaccine was administered was at a Public Health Clinic/Veterans Administration facility. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced strong headache after shot, constant headache during the day of the shot, pain on the arm where the shot was given, tiredness and weakness on 11Feb2021 at 05:15 PM. No treatment received for reported adverse event. Patient not tested for COVID-19 since the vaccination. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.

soreness around injection site; This is a spontaneous report from a contactable Other Health Professional reporting for herself. This is one of two report from same reporter. A 26-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL8982; Expiry date: unknown) as a single dose for COVID-19 immunization on 13Jan2021 at 09:45 in the left arm. The patient past medical history and concomitant medications was not reported. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient was not tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Approximately in 2021, after first dose the patient developed soreness around injection site. The patient reported that the clinical outcome for soreness around injection site was recovering. The patient did not receive any treatment for adverse event. Follow-up attempts are completed. No further information is expected.

The patient felt numbness on left arm (injection site) after getting the vaccine. Had patient rested for 30 minutes, pt started feeling her arm then left to work.

Site: Pain at Injection Site-Mild, Systemic: Bell's Palsy-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Hyperventilation-Medium, Systemic: Shakiness-Medium

Pt c/o feeling tingling and swelling in her tongue and her face after receiving her vaccine. Pt was moved to the Triage room for closer observation. Pt was given oral benadryl and monitored for further symptoms. Pt symptoms continued to progress including itching in her throat and over her face. Pt stated she had reacted to the first dose and was treated with benadryl which successfully managed her symptoms at that time. For this dose, the benadryl did not seem to be effective and d/t progressing symptoms, pt was given IM epinephrine and transported to the ED for further evaluation and treatment.

Jaundice of skin and eyes, symptoms of anemia (shortness of breath, extremity tingling, difficulty exercising), dark urine, yellow tinged stool, yellow tinged body fluids, shortened menstruation. Physically noticed symptoms in early February 2021. Symptoms did not improve so scheduled a clinic visit. Lab tests revealed critical low H&H with no signs of hepatic malfunction or disease. ER visit and consultation with hematologist pointed to diagnosis of Warm Autoimmune Hemolytic Anemia. No family history of autoimmune disease, no previous history of condition, no previous cancer, no prescription medication. Suspect that the vaccine caused condition. Current treatment is high dose prednisone. Treatment ongoing.

Symptoms: pain at the injection site, aching body, fever, feeling cold, feeling tired, and sensitive skin. Time course: about three days. Treatment: acetaminophen. Outcome: I feel fine now.

After about 25 minutes patient came back into pharmacy to report tingling and numbness in right arm. There was a palpable, large, red rash on right arm as well. Patient also complained about itchy top of throat. About 10:15am patient was injected with 50mg of diphenhydramine at site of injection. Pt's blood pressure was normal 148/98 at 10:00am and 147/90 at 10:03am. Patient felt much better in 10 minutes and 90% of rash went away. Patient's husband drove patient home around 10:45am.

PATIENT RECEIVED VACCINE AT 4:15PM ON 5-20-21. EXPERICENCED FEVER, SWEATING, FATIGUE, AND INJECTION SITE PAIN WITHIN HOURS OF VACCINE. NEXT MORNING PATIENT EXPERIENCED ARM, SHOULDER, FINGER OF LEFT ARM MUSCLE SPASMS. LEFT HAND STIFFENED AND LOCKED IN POSTION FOR COUPLE MINUTES DURING DAY. PATIENT DID NOT SEEK MEDICAL ATTENTION BECAUSE SHE SAID SHE WAS TO WEAK TO CALL FOR HELP AND JUST SLEPT. SHE THOUGHT IT WOULD BE BETTER ONCE SHE AWOKE. PATINET DID FEEL SOMEWHAT BETTER NEXT DAY, BUT STILL EXPERIENCING MUSCLE SPASMS AND WEAKNESS AND HAVING DELAYED RESPONSE FOR MUSCLE CONTRACTION. SPOKE TO MD BECAUSE SHE COULD NOT GET APPOINTMENT 2 DAYS AFTER SHOT AND WAS TOLD TO TAKE TYLENOL, BENADRYL FOR SYMPTOMS. PATIENT DID NOT SEEK MEDICAL HELP AT ER DUE TO NO INSURANCE COVERAGE.

Fever, chills, facial rash, nausea, vomiting, lethargy, muscle soreness, headache, all over body aches. Three days later I felt better. It hurt to walk, move, stand. Lymph-node under my left arm (same arm shot was given in) was swollen and painful to move/touch for three days.

fever; chills; sweating; warmth at injection site; lymph nodes swollen and painful; lymph nodes swollen and painful; Body aches; headache; tired; nauseous; This is a spontaneous report from a non-contactable consumer (patient). A 26-year-old female patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 17Feb2021 (Lot number was not reported) as single dose (at age of 26-year-old) for covid-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took amoxicillin and experienced drug hypersensitivity. First dose of bnt162b2 (BNT162B2) was administered on 27Jan2021 (at age of 25-year-old) for covid-19 immunisation. On 18Feb2021 08:00 patient experienced fever, chills, sweating, warmth at injection site, lymph nodes swollen and painful, headache, body aches, tired, nauseous. No treatment was administered for the events. Patient did not have COVID prior vaccination and also patient was not tested for COVID post vaccination. Outcome of the events was unknown. No follow-up attempts are possible; information about batch number cannot be obtained.

It was just swelling, redness, and heat at the site of the vaccination. After sending the picture to my Doctor he thought it was cellulitis and he prescribed me amoxicillin.

Within 5 minutes after the injection I could feel my tongue swell up. My throat did not close. My vision become blurred. When I got home at 4:30 I got a sudden onset of an intense headache in the front of my head by my forehead and by my temples. The back of my neck is sore and so if my arm st the injection site

Rash began to occur around the vaccine site by the morning after given. Then by Saturday Morning it had spread across my upper back and shoulders. On Sunday , it was on my right arm and face. I used Benadryl and Calamine lotion to stop itching and spread.

facial swelling; face rash; This is a spontaneous report from a non- contactable consumer, the patient. A 26 -year-old non pregnant female patient received BNT162B2 (PFIZER -BIONTECH COVID-19 mRNA VACCINE; Lot/Batch number: Ep-7534), via an unspecified route of administration on left arm on 15March2021 at 4.30 pm as second dose of COVID-19 immunization. The patient past drug history included BNT162B2(PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot/Batch Number: En6203) on 23Feb2021 at 4.30 pm. No concomitant medications were reported. Prior to the vaccination patient was not diagnosed with COVID-19. Since the vaccination patient was not tested for COVID-19. On 16March 2021 the patient experienced face rash and facial swelling. Therapeutic measures taken for the adverse events was unknown. Clinical outcome of the events face rash and facial swelling was recovering/resolving at the time of reporting. No follow up attempts are needed. No further information is expected.

was feeling as though as she was going to faint; Her heart was beating fast soon; She also developed a rash to her arm and elbow.; was normally on time with cycle, and it had been off; This is a spontaneous report from a contactable consumer (patient's mother). A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 26 years old, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Mother was calling on behalf of her 26 years old daughter who had received both doses of the Pfizer Covid vaccine. A couple of weeks after the vaccine her daughter while in the shower, was feeling as though as she was going to faint, she was normally on time with cycle, and it had been off, her heart was beating fast soon after she got the vaccine, but it went away. she also developed a rash to her arm and elbow. The reporter asked if an abnormal cycle which has never had was part of the Pfizer Covid vaccine and what about infertility if there were any reports on whether the vaccine would cause infertility. The outcome of the event "Her heart was beating fast soon" was recovered on an unspecified date, of the other events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

arm pain; Red spot on her arm; Had a tiny red circle where the vaccine was administered; It was brighter, more red, warm to touch, and itchy; It was brighter, more red, warm to touch, and itchy; neck pain has been worse than normal on the left side; neck pain has been worse than normal on the left side; Arm was starting to hurt again, in the muscle, it felt tight like a pulled muscle; Low-grade temperature; Body chills; Normal Vaccine Left Arm Pain/where the vaccine was administered; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine), dose 2 via an unspecified route of administration on 09Apr2021 12:30 at 26 years old (LOT: EW0153) as single dose on left arm for covid-19 immunisation. Medical history included polycystic ovarian syndrome (PCOS) from 2016 and ongoing, took no medications; neck pain; headache; Low B12 Values, Issues Absorbing Iron; Anemic; Bad Vitamin Absorption, not lot of Vitamin D in Winter; allergies. Concomitant medications included ongoing cyanocobalamin (VITAMIN B12, Lot 2406217, Expiration: Sep2022) Complex taken for Low B12 Values, Issues Absorbing Iron; ongoing ferritin 325mg Ferris Sulfate, taken for Anemic, doesn't absorb Iron; ongoing colecalciferol (D3 VITAMIN) taken for Bad Viamin Absorption, not lot of Vitamin D in Winter; loratadine Apr2021 and ongoing for allergies; ongoing ibuprofen, only takes one at a time for Neck Pain or Headache. No other vaccines were administered on Same Date of the Pfizer Suspect. The patient previously received the first dose of bnt162b2 (LOT:EP7534) on 17Mar2021 13:30 at 26 years old on Right Arm for covid-19 immunisation and experienced more neck pain than normal; Flu Vaccine a couple of years ago where she felt pretty bad, 2018. As a child she had vaccines, but parents were weird and so she did not get as many of them. Caller (patient) was calling in regards to the Pfizer Covid 19 Vaccine. She called to find out if the side effects she was experiencing are normal. She experienced Normal Vaccine Left Arm Pain/where the vaccine was administered on 09Apr2021. The day following the second dose on 10Apr2021, she had a low grade temperature and body chills and it went away. Caller had normal arm pain after the vaccine which mostly went away. On 24Apr2021, her left arm started to hurt again, this was in the muscle and it felt tight like a pulled muscle. After a couple of days this started to go away and she noticed a red spot on her arm, 1 inch lower than where she got the vaccine and she said it was the size of a small medium size potato. Also mentioned she has a tiny red circle where the vaccine was administered. Caller states it is still hurting and has been hurting for the past 2 weeks. Caller states the red circle yesterday was brighter, more red, and warm to touch and itchy. Caller states it is weird to her because it has been a month since the vaccine. Caller clarified, the red circle is not an inch below, it is about 4cm but it is a little bit lower. States there is a very clear difference, distance between the two. Caller states the redness she noticed Friday or Saturday of last week 30Apr2021 or 01May2021, and it looks more faded but it had gotten brighter. States it does not hurt anymore, it just itches under the skin like a bug bite, and it is a little bit warmer than the normal skin. Caller states she was messaging her friend about her arm pain, and said it was like she got another shot and it had started to go away and then it started hurting again on Tuesday 04May2021. States the redness started on Saturday or Sunday. States her mom is a nurse so she sent a picture to her, she thinks it happened before Monday. She is unsure of exact start date. Caller states she had normal vaccine arm pain for only a couple of days because she remembers she went on a long hike and she was not paying attention to it. States she was hanging out with a friend and noticed her arm was hurting on 24Apr2021, and she thought it was odd because the vaccine was 2 weeks before. States she thought it would go away, the pain did but now it is red and itchy. States it doesn't itch really bad, but if it brushes clothing or she moves her finger over it is itchy. Caller states her neck pain has been worse than normal on the left side. States she is not sure if it is related to the muscle in her arm. States it is not super bad, but she notices it. Unknown Start Date. States she knows it has been worse this week. States she works on computer though, so she may be sitting weird. Time of Onset (24-hour clock): Fever and Chills 08:00 10Apr2021. Treatment included: Took Tylenol initially the day she had fever and chills. Caller states she just thought it was probably weird because she still had it 2 weeks after but it was not hindering her life, but she thought since it has been a month now, she should call and tell us. The events didn't result in emergency room or physician office, suggested she should since it has been a while. Relevant Tests were none. The outcome of "a low grade temperature and body chills" was recovered on 10Apr2021; of "Normal Vaccine Left Arm Pain/where the vaccine was administered", "Arm pain" and "Arm was starting to hurt again, in the muscle, it felt tight like a pulled muscle" was recovered on an unspecified date; of "neck pain has been worse than normal on the left side" and "red spot on her arm", "tiny red circle where vaccine was administered", "red circle yesterday was brighter, more red, warm, itchy" was not recovered. The reporter considered the case as non-serious. Follow up attempts are completed. No further information is expected.

Burning at injection, soreness at injection5 to 9 hourafter injection, I feel some shotting pain down arm occasionally. Slight pressure in head but not full on headache within 2 hours of headache.

Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Additional Details: contacted paramedics pt did not want epipen...did not want to go to er

After 7 hours I noticed a rash all over my body. At this time I have bumps all over. I will be going to visit a doctor if the rash gets worse and does not improve within 24hrs of the 1st dose.

I got the regular side affects that were warned about, however, I also got allergies for the first time in my life a few days after. I lived somewhere else this time last year and was not affected by the pollen, but after I got the shot I got allergies every time I went outside. I am not sure if it is a coincidence or if the shot had messed up my immune system in any way. My allergy symptoms occur when I go outside and consist of runny nose that turns into stuffed nose, sneezing, and eye irritation. it is worse when it is cold and have occurred every day since it started. regular side effects that I was warned about that I experienced was pain in the shot area and barely able to lift my arm for about 24 hours. heavy body flu type of symptoms the first night, second night I started having a runny nose and felt a little sick. then the next day or a day after I started having bad allergies when going outside that I am still experiencing 13 days after my first shot.

As per pt self report, "after I took the COVID19 Pfizer vaccine, about 48 hours afterwards I developed blisters all over my body. On my face about 100, in my mouth, arms, legs, feet, just all over. I did a televisit with a doctor. I do not have a PCP, so the person I spoke with my insurance plan referred me to Doctor (pt does not have the phone number for MD) and he said it was an allergic reaction. The doctor prescribed Hydrocortisone and told me to take Benadryl and Claritin. It got worse the next day and over time. It took about a week to resolve"

severe hives/hives measured about 2 inches thick and 6 inches long in some places on my body/I just had hives that were itchy; severe hives/hives measured about 2 inches thick and 6 inches long in some places on my body/I just had hives that were itchy; My throat did not close; This is a spontaneous report received from a contactable consumer or other non hcp. A 26-years-old non pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Batch/Lot number: EM9809; Expiry date: unknown), via an unspecified route of administration in the left arm on 06Feb2021 13:00 (age at vaccination 26 years old) as a single dose for COVID-19 immunization. The patient medical history was not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient received other mediations in two weeks. Concomitant medication(s) included ethinylestradiol, norethisterone acetate (JUNEL) and amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) 15xr taken for an unspecified indication, start and stop date were not reported. The patient did not have COVID prior to vaccination. On 09Feb2021 12:00pm the patient experienced severe hives 3 days after getting the shot. The patient did not have sensitive skin and had never broken out in hives like she did. The hives measured about 2 inches thick and 6 inches long in some places on her body. The patient throat did not close, and she didn't have any trouble breathing, she just had hives that were itchy. No treatment was received for the events. No covid tested post vaccination. The clinical outcome of the events was recovered. No follow-up attempts are possible. No further information is expected.

After receiving the vaccine I passed out. Waited the 15 minutes then got into my vehicle. At that time my entire body felt as though it was on fire and I broke out in hives. Had trouble breathing. Went home, took Benadryl and waited it out. Breathing went away a few minutes later but hives stayed for 3 days. My arm was swollen and tender the next day and stayed swollen for 4 days.

Patient started to complain about hives and itching on torso and chest area after approximately 30 minutes post immunization.

Patient came into the store with her mother to get her firs Covid 19 vaccination. At we carry Pfizer brand. She received the vaccination and was walking around the store she passed out and hit her lip on way to floor. Upon seeing the patient on the floor I came over to the mom to provide assistance. She was awake, however, very lethargic. I was very concerned that the patient was not coming out of the syncope fast enough. Therefore, I called 911. The fire dept. was first to arrive. They checked her vitals and asked her many questions. All vitals were in normal limits and she correctly answered their questions. The EMTs arrived and re checked vitals. All vitals still showing normal limits. They are to put her in the ambulance and take her to hospital. The patient refused and the EMTS walked the patient to her car and I returned to the pharmacy. I called patient at 6:00pm that night and mom informs me that did go the ER later because of a rash all over body. Mom states that is feeling better after hospital visit.

Pt presented with a rash that is healing after the first shot. Pt experienced itching and heat the day after the first shot at a location on the lower abdomen near the hip bone. Pt didn't experience any fever. So at the area of the itching, a rash developed about a week after the shot. Pt has been taking Benadryl and hydrocortisone cream to ease the itching since then. Pt continued to itch the area if she didn't have any relief from the hydrocortisone. On 6-14-2021. pt received the 2nd shot in the right arm. She was instructed to come into the pharmacy or call us as needed to update us on her condition.

4 days after receiving my second dose of Phizer I developed an itchy bump on my right shoulder, 06/12/2021. By 06/15/2021 the bump spread into a rash so I went to my primary care physician. My PCP diagnosed me with shingles, and stated that I was the second case of shingles he had seen in the day, which was odd to him. When I left the doctors office I called my father to tell him about my shingles. He informed me my grandmother also just recovered from a case of shingles. When I got home I searched ?shingles? on Twitter and searched the latest tweets to see if it was common. I came across many tweets of people reporting shingles/chickenpox after their covid vaccination. I called my father to see if my grandmother who just recovered from shingles had been vaccinated. He confirmed she broke out in shingles after her second covid vaccination also.

At 9 pm on June 14th, 8 hours after vaccine, patient began getting extremely itchy hives all over stomach, left arm, right arm, neck, breasts, and back.

Opposite side of face face swelled; headache; got a "frozen shoulder" from vaccination side on same side.; got a "frozen shoulder" from vaccination side on same side.; This is a spontaneous report from a non-contactable Other HCP reported (herself). A 26-year-old (Non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown) via unspecified route of administration in left arm on May2021 (at age of 26-years old) as 1st dose, single dose for COVID-19 Immunization. Patient medical history includes Asthma from unspecified date to unknown till ongoing. Patient had known allergies of lot- latex, nickel, avocados, kiwis, peaches, etc. Patient concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not tested for COVID. On 21May2021 18:00, patient experienced opposite side of face swelled, headache, and got a "frozen shoulder" from vaccination side on same side. Treatment received by patient for adverse events is BENEDRYL. The Clinical outcome of events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

slight "numbness and tingling" in bilateral arms and legs; slight "numbness and tingling" in bilateral arms and legs; they punctured her vessel with the vaccine with some heavy bleeding; slight chest tightness; This is a spontaneous report from a contactable other health care professional. A 26-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: EW0217, brand: Pfizer), via intramuscular route of administration, administered in arm right on 12Jun2021 14:00 (at the age of 26-year-old) at 1st dose, single dose for covid-19 immunization. Medical history included Autoimmune disorder (Sjorgen), Boils, GERD (Gastrooesophageal reflux disease). Patient was allergic to Sulfa drugs, Latex, Bactrim, Environmental. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications (which the patient received within 2 weeks of vaccination) included pantoprazole; cetirizine; xylometazoline hydrochloride (NASAL SPRAY II); aluminium hydroxide, magnesium hydroxide (MYLANTA SIMPLE); dupilumab (DUPIXENT); doxycycline. The patient received their first vaccine on 12Jun2021 at name. The patient stated they punctured her vessel with the vaccine with some heavy bleeding that resolved after several minutes. Then after 10 minutes complained of slight chest tightness but after 30 minutes symptoms subsided. The patient stated that at 4 am on 13Jun2021, experienced slight "numbness and tingling" in bilateral arms and legs. States it feels like when your feet just waking up. Patient did not receive treatment for the adverse event. Outcome of the events slight "numbness and tingling" in bilateral arms and legs was resolving and the events punctured her vessel with the vaccine with some heavy bleeding, slight chest tightness was resolved on 12Jun2021. Information on Lot/Batch number is available; Further information has been requested.

Client received 2nd COVID vaccine of Pfizer (Lot# EW0186 expiration 07/12/21) at 1358. Client is being observed in vaccination room with PHN. At 1406, Client reports lightheaded, numbness at the injection site (left arm) and tingling in the left fingertips to PHN. Client reports a history of anxiety, no medications, and has an allergy to tofu/soy. Client was placed onto the zero-gravity chair. At 1412, RN obtains vital signs which are blood pressure 140/82, heart rate 92, oxygen saturation 97%. At 1416, lightheaded is improving, but numbness and tingling is still present. RN assisted in translation. PHN and RN educated Client about common adverse effects on the COVID vaccine and ED precautions. Client was offered and accepted both water and snacks. At 1421, vital signs are blood pressure 152/80, heart rate 82, oxygen saturation 95%. Client denies headache, shortness of breath, chest pain, lightheaded is improving, numbness and tingling of the arm and fingertips are the same, and reports "feeling heavy" and feels "a little sleepy." PHN offered to call emergency services for further evaluation and Client accepted. At 1426, vital signs are blood pressure 132/82, heart rate 86, oxygen saturation 96%. At 1427, emergency services was called by PHN and arrived at 1435. Emergency services arrived and assessed Client. Client denied transfer to hospital for further assessment and reports tiredness is improving. At 1442, Client goes against medical advice from the emergency services. RN waits with Client as client calls for a ride to pick her up. At 1447, Client reports "feeling better'" while eating Pringles and drinking water. Client states "muscle tightness in the body coming from the back". PHN advises Client to follow up with primary care provider. At 1454, client states feeling "nothing serious" and only tiredness. RN is with Client for observation. At 1540, client is walked to the bathroom with RN. Client denies dizziness, shortness of breath, chest pain, lightheaded, and pain at injection site. At 1546, Client's father arrived. Client stood up with no complaints and with a steady gait. RN and Ancillary accompanied Client to car.

Fever; muscle aches; chills; fatigue; rash on arms; This is a spontaneous report received from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in left arm on 17Mar2021 at 13:15 (at the age of 26-year-old) as a single dose, for COVID-19 immunisation. Medical history was not reported. The patient received birth control (MANUFACTURER UNKNOWN) within 2 weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown), via an unspecified route of administration in left arm on 24Feb2021 at 00:00 hours (at the age of 26-year-old), as a single dose for COVID-19 immunisation. Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Since the vaccination patient had not been tested for COVID-19. The patient had codeine allergies. On 18Mar2021, the patient experienced fever, muscle aches, chills, fatigue and rash on arms. The patient did not receive any treatment for events. The clinical outcome of the events fever, muscle aches, chills, fatigue and rash on arms were recovering. No follow-up attempts are needed. No further information is expected

lingering headache; fatigue; soreness around injection site; chills; fever; This is a spontaneous report from a contactable other hcp (patient). A 26-years-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EL8982 and Expiration date: unknown), via an unknown route of administration, in left arm on 03Feb2021 at 08:30 (at the age of 26-year-old) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously took bnt162b2, administered in left arm on 13Jan2021 at 09:45 (Lot number: EL8982) and experienced soreness around injection site. Patient did not receive any other vaccine within 4 weeks prior to the covid-19 vaccine. Prior to vaccination, patient was not diagnosed with covid-19. Patient has no allergies to medications, food or other products. Since the vaccination, patient has not been tested for COVID-19. On 03Feb2021 at 21:00, the patient experienced soreness around injection site, chills/fever approx. 12 hours post-injection. On 04Feb2021, the patient experienced lingering headache and fatigue even 24 hours post-injection. The case was assessed as non-serious by the reporter. Patient did not received treatment for events. Outcome of events was recovering. Follow-up attempts are completed. No further information is expected. .

Pain in arm at injection site.; Nightmares; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 18Mar2021 (at the age of 26-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not provided. The patient was not allergic to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not tested for COVID-19 since the vaccination. On 19Mar2021, the patient experienced pain in arm at injection site and nightmares. The patient did not receive any treatment for the reported events. The clinical outcomes of the events vaccination site pain and nightmares were unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained

Scaly painful rash forming around lips, has grown up both of my cheeks and around my left eye. It has also formed on my neck knuckles and hands. Its bumpy like braille individual bumps with space between the next bump. On my face it burns, and is dryer. I am itchy eveywhere to the point that I cannot sleep. I have taken an allergy pill today to try and get relief but I must admit this isn't pleasant.

Patient has hives 30 minutes after vaccination. Patient states she found out she's allergic to oat this morning after having oatmeal for breakfast (she broke out is hives and itchy mouth). After her hives died down she came in to get her vaccine then had hives again 30 minutes after. She took benadryl and felt better after.

Body aches in arm, back and pelvic area. Fatigue and body weakness after first vaccine for two days. Diarrhea, stomach discomfort, mild fever and body aches after second vaccine. Month following adverse reaction to vaccine, new allergies to food and products, GERD, diarrhea, mild fever, fatigue, dehydration and body ache at vaccine sites on arms. Diarrhea was continuous during the months of April, May and June as a result to certain food. Specific food was eliminated from diet. Such as carrots, broccoli and egg. Diet consisted of fruit smoothies, turkey/ham with crackers and steak tacos. In continuation, body aches/pains and shortness of breath developed as a result to certain food. New diet restrictions were placed in accordance to food allergy test that showed new food allergies. Constipation was treated after using bismuth. Treatment for GERD, body aches/pains, mild fever, allergies, dehydration, UTI: pantoprazole, Tylenol, allergy liquid medication, antibiotic, IV and cranberry D-mannose.

Patient developed rash on left arm initially within 24 hours of receiving the injection. Rash progressed to right arm, abdomen, back, and bilateral lower extremities. Rash was red and itchy.

Full body hives spread out only about 10 in total lasting more then 24 hours. Red blotchy non bumpy rash on both arms lasting more then 24 hours. Heavy feeling in chest lasting more then 24 hours. Severe muscle and joint aches lasting more then 24 hours. Extreme tiredness lasting more then 24 hours. Brain fog lasted less then 24 hours.

Dark yellow bruises on right side; This is a spontaneous report received from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955), via unspecified route of administration in the right arm on 22Mar2021 (Monday) at 13:30 (at the age of 26 year-old) as single dose for COVID-19 immunisation. Medical history included cochlear implant in left ear and COVID-19. Concomitant medications included ethinylestradiol, norgestimate (TRI-LO-MARZIA) taken for an unspecified indication from an unknown date. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. The patient had not tested for COVID-19, since the vaccination. On 23Mar2021 (Tuesday), the patient experienced dark yellow bruises on right side, one on arm, four on thigh. All ranging in sizes from dime sized to quarter size. The patient did not receive any treatment for the adverse event. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome for the event bruises was unknown. No follow-up attempts are needed. No further information is expected.

Pt received first dose pfizer covid-19 vaccine on 5/4/21. Per pt, she noticed a swollen lymph node in left armpit 3 days after receiving vaccine. The swell reduced for a few days. Swelling is now increased again and slightly larger than when it first appeared. Pt said, she also noticed rash on left arm two nights ago. urgent care appt set-up for patient 5/19/21.

Site: Pain at Injection Site-Severe, Systemic: SWOLLEN LYMPH NODES-Severe, Systemic: Lymph Node Swelling-Severe, Additional Details: PATIENT VISITED HER DR SINCE SHE HAS BEEN EXPERIENCING PAIN IN HER BREAST AND WAS TOLD THAT HER LYMPH NODES ARE SWOLLEN DUE TO COVID VACCINE.

Redness and swelling at injection site 2 days following injection fever, nausea and fatigue 1 day following injection

After getting the 2nd shot, I had no issues other than arm pain. On the 3rd of May, about 3 days later, I started feeling a burning sensation in my chest. The sensation could be felt on the top left of my chest. It was an ongoing feeling. At times I also felt the same sensation at the injection sight. Sometimes there was an achy feeling but the burning was more prominent. On that wednesday, I decided to go to Urgent care as the symptoms did not stop. They had me do a chest xray but did not see any cause for concern and so I was sent home and told to keep an eye on it and that if I had any difficulty breathing or terrible pain in my chest, I should go to the ER. That Saturday, May 8, I went to my doctor's office because I was getting worried and the sensation was not going away. I had begun to feel some chest tightness every now and again. It had now been a week. I was seen by a doctor who said that the vaccine can cause lymph node swelling and that was probably what was happening to me. She felt my chest and arm and said that she could feel swelling. I could feel a bit of swelling in my arm but nowhere else. There were no visible lumps or anything like that. But she said not to worry about it and that it will go away. After another week, I went to my actual doctor for a check up (May 15). After explaining to her what was happening and the anxiety it was causing me, she did an EKG. Results of that were normal and she also did not see any cause for concern. By this time, the sensation had begun to subside. After that day, I did not feel the sensation any more. All and all, the whole ordeal lasted about 2 weeks after getting my second shot

Pt injected at 10:22. 10:30 Pt c/o "itching all over", no redness/raised area noted. 25mg Benadryl p.o. administered. 11:00 pt stated "I don't feel itchy anymore". Pt dismissed and given emergency management information.

Site: Itching at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Tingling in fingers and foot-Medium, Systemic: Nausea-Medium, Additional Details: Paramedics were called to assess patient and because she didn't have difficulty breathing she decided not to go with them. her husband came and she said he would take her to urgent care.

Red swollen area about 4inches long hurts to touch and itches. Rash on face all the way down to the chest that itches.

Fatigue; Pain at site of injection; Swollen lymph nodes in lower right of neck; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration in the right arm on 27Mar2021 at 13:30 (at the age of 26-years-old), as a single dose for COVID-19 immunisation. Medical history included primary lymphedema in lower extremities. Concomitant medication included allergy medication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205), via an unspecified route of administration in the right arm on 06Mar2021 at 13:00 (at the age of 26-years-old), as a single dose for COVID-19 immunisation. The patient had not received any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 28Mar2021 at 16:00, the patient experienced fatigue, pain at site of injection and swollen lymph nodes in the lower right of neck. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for events fatigue, pain at site of injection and swollen lymph nodes in the lower right of neck. The clinical outcomes of the events fatigue, pain at site of injection and swollen lymph nodes in the lower right of neck was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Chills; slightly sore at injection site; nausea; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in the left arm on 25Mar2021 at 10:00 (at the age of 26-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not take receive any other medication within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Mar2021 at 20:00, the patient experienced chills, slightly sore at injection site and nausea. No therapeutic measures were taken as a result of the events. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events chills, vaccination site pain and nausea were unknown at the time of this report. No follow-up attempts are needed. Information about lot/batch number cannot be obtained.

Arm started feeling sore, tender, and warm to the touch, itchy, and a hard lump formed at the vaccination site about 8-9 hours after vaccination. Started having headache, body aches, stuffy nose, and fatigue around the same time. Headache, body aches, stuffy nose, and fatigue lasted roughly 24 hours and improved slightly with Tylenol, Ibuprofen, and rest. Injection site swelling and pain were made better by an ice pack, but symptoms are still present 48 hours after vaccination.

Patient woke up the morning after Dose #2 with lower body allodynia, up to the pubic bone. Pain with clothing or bedding being in contact with skin on legs/buttocks bilaterally. Patient took 5-325 oxycodone/acetaminophen and could only tolerate bed rest for the next 8-12 hours. Condition had completely resolved by 36 hours after vaccination

Headache; chills; joint ache; fatigue; injection site pain; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 30Mar2021 at 19:15 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient did not have any allergies to food, medications, or other products. The patient did not receive any concomitant medications. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021, the patient experienced headache, chills, joint ache, fatigue and had injection site pain. Therapeutic measures were taken as a result of the events headache, chills, joint ache, fatigue and injection site pain which included treatment with ibuprofen (MANUFACTURER UNKNOWN). The clinical outcomes of the events headache, chills, joint ache, fatigue and injection site pain were resolved on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.

Initial Pfizer injection: resulted in no symptoms except slight fatigue and soreness at injection site. Day 1 after second dose: Two brief periods of chest pain. Day 2 after second dose: Upon waking up the next day from receiving my second dose, I had extreme chest pain, but no difficulty breathing. This was exacerbated when bending down (producing an almost nauseating feeling) and/or lifting my arms. Sitting up without support increased discomfort while laying down made things more tolerable. After home testing: my blood pressure, it ranged from 103/70 to 108/70; temperature never reached over 98; and oxygen levels were 96-98. I felt as though I could feel my heart beating against my chest and generalized pain as though there was a heavy weight directly under my sternum. After napping, the pain subsided, but would always return. After activity as small as making lunch, the pain returned in full. Pa Day 3 after second dose: Woke up to chest feeling tired, as though strained and the pain could return at any moment. Still a constant dull ache. Blood pressure came in at 111/65 and resting heart rate at a range of 73-83 thus far. Trying to take it easy today so as not to cause the pain to return. General notes: I've been taking Ibuprofen and later Naproxen Sodium (ran out of the former) for pain up until day 3 (testing to see if the pain returns in full) and Zyrtec for general/pet allergies. Have taken Olly Goodbye Stress gummies up until day 3 in case of anxiety/stress worsening my condition.

Itching started around 40 minutes after vaccination (arms, face, head, neck, back, legs, ears, eyes, and nose) and lasted 5 hours, then came and went through 7/10 with milder intensity. Took allergy medicine 7/10. Face redness for 3 hours after vaccination. Slight cough with clear mucus a handful of times and felt chest congestion on 7/10.

Arm pain near site of shot; feverish; exhaustion; chills; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration on 01Apr2021 at 10:45 (at the age of 26-years-old), as a single dose for COVID-19 immunisation. Medical history and concomintant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021, the patient experienced arm pain near site of shot, feverish, exhaustion and chills. The clinical outcome of the events arm pain near site of shot, feverish, exhaustion and chills was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.

"Pt was vaccinated at 10:02 and @10:16 patient reported severe itching tochest, neck, and BUE. Patient appeared to be anxious and hypervigilant upon assessment. Patient stated ""I sometimes get itchy when I am exposed to the cold."" Patient stated she was unsure if the itching was due to the vaccination or due to the exposure to the cold. Patient reported she was nervous getting the vaccination due to the side effects and as a result have delayed signing up for an appointment until today. Patient scratching at skin. Mild dermatographia on skin which appears to mostly be contributed to patient itching at skin. No visible hives or any uniform raised bumps on patient's skin. Scratch marks/dermatgraphia and erythema/edema visible on left axilla, right forearm, and surrounding neck area. Patient denies any SOB or chest pain/tightness. Denies any angioedema, edema in in the throat, tongue swelling, throat itching. VS as follows 10:20 154/108, HR 85, RR 19, 97.0F, Sp02 99% on RA. LSCTA. 10:21 25mg PO Benadryl was administered to patient's reports of purititis on skin. 10:30 145/85, HR 75 RR 17, 97.9F, 99% on RA. LSCTA 10:40 Patient reports less symptoms at this time, stated she felt good enough to go home. 10:45 143/85, HR 75, RR 17, 98.2F, 97% on RA. Patient advised to receive J&J for second COVID vaccination in 28 days. Patient was advised to follow up with PCP due to SBP of greater than 140 and family history of HTN. Patient verbalized understanding. Patient advised to seek immediate medical care if itching worsens or persists or any other symptoms manifest. Educated patient on S/S of allergic reaction including: hives, continued itching, SOB, throat itching, facial swelling, chest pain. Patient given written discharge instructions. Patient stable at time of discharge. Patient voiced no further questions or concerns at this time. Time of discharge: 1050 1758 Called to F/U with patient. Patient reported she was feeling better and did not have any further questions at this time."

High fatigue; Injection site pain; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734), via an unspecified route of administration in the left arm on 30Mar2021 at 15:00 (at the age of 26-years-old), as a single dose for COVID-19 immunisation. Medical history included asthma and hazelnuts allergy. Concomitant medications included salbutamol (ALBUTEROL INHALER) and PORTIA birth control pill, both for an unknown indication and from unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route on an unknown date, as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 04:45, the patient experienced high fatigue and injection site pain for 72 hours The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of reported events. The clinical outcome of the event high fatigue was recovered on an unknown date in 2021; while that of the event injection site pain for 72 hours was recovered on an unknown date in Apr2021. No follow-up attempts are possible. No further information is expected.

Patient received vaccine dose 5/13/21 at 1754. The patient reported extreme pain and soreness on 5/14/21. Two days after her second vaccine shot (5/15/21) she presented with a rash on her right facial cheek and chest. Her right ear was also red and the patient complained of having an "itchy tongue." Patient received tylenol and benadryl. A few hours later, the patient reported the pain was getting were and the RN did a full assessment and found that the patients rash had become worse on her ear and that the patient's speech was slurred. Vital signs were obtained and WNL. No respiratory distress. Pt sent to ED for evaluation and returned later that evening to Rehab facility.

Itchy arms,; Red and small bumps; Headache; Body aches; This is a spontaneous report from a non-contactable consumer or other non-health care professional (patient). A 26-year-old female patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date: Unknown), via an unspecified route of administration on 30Mar2021 at 13:00 (at the age of 26-year-old) as single dose for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. The patient had a history of allergy to lamb, dairy, corn and potatoes. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the COVID-19 vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19. On 30Mar2021 at 21:00, the patient experienced Itchy arms, red and small bumps, headache and body aches. The patient did not receive any treatment for the adverse events. The adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events of Itchy arms, red and small bumps, headache and body aches were resolving at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot be obtained. Amendment: This follow-up report is being submitted to amend previously reported information: Treatment Received selected as No for Headache.

Arm is just so itchy; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6208), via an unspecified route of administration in the arm left on 19Mar2021 at 16:00(at the age of 26-year-old), as a single dose for COVID-19 immunisation. Medical history included asthma, endometriosis, cystitis interstitial and immune thrombocytopenic purpura (ITP) from an unknown date. The patient was allergic to banana, pineapple, latex and prednisone. Concomitant medications included cetirizine hydrochloride (ZYRTEC), levonorgestrel (KYLEENA), AFFAIR and SINGULAR started on an unknown date for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Mar2021 at 19:00, the patient's arm was just so itchy, even 4-5 days later. There was no redness. It was not even warm. But the inside of patient arm itches so badly. The patient did not receive any treatment for the event. The adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event arm just so itchy was resolving. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0151), via an unspecified route of administration in the arm left on 02Apr2021, as a single dose for COVID-19 immunisation. No follow-up attempts are needed. No further information is expected.

severe rash all over upper chest, breasts, upper shoulders red, pimply with whiteheads; severe rash all over upper chest, breasts, upper shoulders red, pimply with whiteheads; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 30Mar2021 at 14:00 (at the age of 26-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19 on an unknown date prior to the vaccination and known allergy to penicillin. Concomitant medications included norethisterone acetate, ethinylestradiol, ferrous fumarate (CHARLOTTE 24 FE) 1 daily for birth control from unknown date. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 the patient experienced severe rash all over upper chest, breasts, upper shoulders. The rash was not itchy and did not hurt or burn, just red and pimply with whiteheads. The patient underwent lab tests and procedures which included nasal swab for COVID-19 virus test on 06Apr2021 and the results were pending. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event rash and red rash was recovered on an unknown date 2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Joint pain; tiredness; injection site soreness; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Apr2021 at 14:30(at the age of 26-year-old) as a single dose for COVID-19 immunisation. No relevant medical history. The patient did not have any allergies to medications, food, or other products. Concomitant medications included etonogestrel (NEXPLANON) for unknown indication from unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Mar2021 at 16:00(at the age of 26-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 18:30 the patient experienced tiredness ,injection site soreness(vaccination site pain) and Joint pain. The patient did not receive any treatment for the events. The events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events tiredness, injection site soreness(vaccination site pain) and joint pain were recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Lots of back pain; Fever of 99 F; Severe arm soreness at injection location; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EU6207), via an unspecified route of administration in the left arm on 22Mar2021 at 13:30 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included inflammatory arthritis. Concomitant medications included sulfasalazine (SULFASALAZINE), methotrexate (METHOTREXATE), meloxicam (MELOXICAM) and folic acid (FOLIC ACID) all taken from unknown dates for unknown indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On an unknown date in 2021, the patient experienced a fever of 99-degree Fahrenheit for 4 hours, severe arm soreness at injection location (vaccination site pain), lots of back pain and fatigue. The events did not result in a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the events experienced. The clinical outcome of the events lots of back pain, fever of 99-degree Fahrenheit, severe arm soreness at injection location (vaccination site pain) and fatigue was resolved on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.

Injection site pain; Fever; Sore muscles; Sore body; Nausea; Hot flashes; Swelling of tonsils; Throat pain; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 02Apr2021 at 15:30 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any medications within two weeks prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021 at 19:45, 4 hours after the vaccination, the patient experienced injection site pain, fever, sore muscles/body, nausea, hot flashes and swelling of tonsils/throat pain. The adverse events neither resulted in doctor or other healthcare professional office/clinic visit nor emergency room/department or urgent care. The patient did not receive treatment for the reported adverse events. The clinical outcome of the events injection site pain, fever, sore muscles/body, nausea, hot flashes and swelling of tonsils/throat pain was resolved on unknown date in Apr2021. No follow-up attempts are needed. No further information is expected.

Sore from arm to chest, tingling/sensitive skin, chills, swollen /painful arm pit on arm were vaccine was received.

Pt.'s mother reports that after receiving the 1st dose of Phizer 07/20/2021, started experiencing 07/26/2021 numbness of hands and arms. Hands are white at the knuckles, Urgent Care visit 07/27/2021 vitals within range, tenderness in the feet and hands including tongue (pins and needles). Reporting temporary dizziness lasting a week, hands numb upon wakening. Currently in route to ER for continuing symptoms.

Fatigue; chills; pain at injection site; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 20Apr2021 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history and past drug. The patient received unspecified medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021 the patient experienced fatigue, chills and pain at injection site. The clinical outcome of the event fatigue, chills and pain at injection site was resolved on unknown date in 2021. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

her heart is racing and feels like it is going to beat out of her chest. Her nerves are so bad right now she is about to have a heart attack; weird bumps, explained as one red spot in right upper arm; weird bumps, explained as one red spot in right upper arm; Her nerves are so bad; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FA6780) via an unspecified route of administration in right upper arm on 15Jul2021 at around 09:00 (at the age of 26-year-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient had no medical history (none) and no relevant family medical history. Concomitant medications were not reported. Patient had no vaccines within four weeks of COVID-19 vaccine. Patient had no history of adverse event following vaccination. On 15Jul2021, after receiving first dose of vaccination, patient was breaking out in weird bumps and had one red spot in her right upper arm. She reported that about an hour after the shot she took a magnet and put it to her arm at the place she got the shot and it stuck, the magnet did not move. On 15Jul2021, patient experienced her heart was racing and felt like it was going to beat out of her chest. Her nerves were so bad, she was about to have a heart attack. Patient asked what she should do, should she go to the doctor or the emergency room. Patient did not receive any treatment in response to the event. Outcome of the events were unknown. Follow-up attempts are completed. No further information was expected.

Petechiae all over face, neck, chest; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01May2021 at 13:30 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any medication within two weeks of the COVID-19 vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Apr2021 at 13:30 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02May2021 at 13:00, the patient experienced petechiae all over her face, neck and chest. The clinical outcome of the event petechiae all over the face, neck, chest was not resolved at the time of this report. No follow-up attempts are needed; information about lot number cannot be obtained.

I woke up with significant right-sided facial and eye swelling currently still present although improved in severity. Other symptoms included pain/heat at injection site, myalgias, fatigue.

shoulder redness/itching/warmth starting 7 days after injection. Advised to use warm compress/Tylenol/Benadryl. Advised f/u in UC or ED for any new/worsening symptoms of any kind

Patient started develop itchy rash on arm near injection site. The diameter of the rash was about 4 inches and developed in about 20 minutes after injection. We gave her an ice pack to apply over the area and a tablet, crushed of Benadryl.

received covid vaccine 12/30 then had rash on r side of face little shooting headache muscle weakeness on 12/31 11:00 am notices pins needles on left side of face. Resolved then at 5 pm it came back again for a few hours then went away. Then 1/1/21 left forhead tingling above eyebrow. Today feels a little stiffness on the side of my face. Also reported left ear hot and painful 12/31 at 11:00

The Sunday after I received the vaccine I had increased hip pain and Sunday night I had a rash anon the L2 and L3 dermatome. I thought it was shingles and made an appt. Overnight the rash spread and it was very painful, On Monday I got Volcite for 7 days and I still have rash (improving) and pain today.

Experienced muscle aches and redness at site of injection, body aches overall, and fever. I was tested for covid-19, flu, and a urinalysis was performed. All tests gave negative results. Ibuprofen was recommended for symptom management.

sore injection site the next day, next day at 10am began experiencing aches in my joints and achey muscles all over, mild headache, fatigue. At around 1pm experienced chills and fever. Experienced 3 episodes of diarrhea that started about 5 hours after the vaccine.

12/31 Fever and Boday Aches 1/1 Itchy rash, both arms Treatment Tylenol, Benadryl, Hydrocortisone creme Outcome as of 1/4, fever gone, rash continues.

Approx 3 min after vaccine administration hives and redness began to develop on chest and quickly ascend upwards to face. Had swollen/"thickening"/tightness feeling in neck. HR 115-120, sweaty and shaking slightly. 50mg PO Benadryl administered immediately. Taken to Emergency Department where IV SoluMedrol and Pepcid were given with improvement of symptoms. Vital signs and symptoms improved by discharge from Emergency Department.

I experienced swelling in my face and lips, my chest became covered in hives. I was nauseated and felt like their was acid in my stomach (burning sensation). I had a headache. Was in the ED 12/31/20. Symptoms continue to happen at random.

I experienced swelling in my face and lips. Hives on my chest and neck. I went to the ED 12/31. I felt nauseated and there was a burning in my stomach. I had a headache. I have been experiencing these symptoms at random since the vaccine.

Patient developed acute pain, itching and warmth at site of vaccine administration. She developed a rash extending to the top of the LEFT shoulder into the LEFT earlobe

Soreness from site of shot that radiated to most of my muscles and joints including shoulders, back, wrists, hips, and thighs. I also experienced nausea and a slight headache. I was unable to sleep because of my symptoms for at least 5 hours. I still am having some symptoms or aching as of 11:30am on 01/07/2021

Beginning January 2nd, 11 days after my covid vaccine I developed right sided back pain. Two days later I had an area of papules on my anterior thigh the size of a half dollar. The right sided back pain then began to radiate around to my hip and the rash began to be painful. My right thigh eventually began to tingle and and the pain increased in severity. On Jan 7th I presented to the acute care clinic at the Clinic and was diagnosed with shingles.

Day off: Arm sore One day after: Lump, arm sore, body aches, trouble breathing 2nd day to current: injection site lump is sore and itches, trouble breathing, body aches

Approximately 24 hours after receiving dose 1 of the Pfizer vaccine, I began having chills and vomited. My fatigue became more severe as well. Later that evening my fatigue persisted and I noticed a rapid heart rate via my Watch. My resting heart rate which usually is about 80 BPM was at 100 while laying down and not engaged in any physical activity. When I stood I was dizzy and had poor balance. While my entire arm no longer hurt, the injection site showed a bump as well. When I awoke the next day my heart rate appeared normal again, and I wasn't especially fatigued compared to before I got the vaccine. I did experience another minor gastro-intestinal episode later that afternoon, but otherwise my symptoms appeared to have passed aside from the fatigue. By the end of my work day I was very tired again, although it is uncertain if this is due to the vaccine or from my continued recovery from Covid and adjusting to the physical demands of going back to my job in-person. Because I received my vaccine on the same day as my first day back to work, I have no experience working post-covid before having the vaccine to compare my current state of fatigue to. On the evening of 01/07 I noted that fatigue was slightly less pronounced. I do not currently have a primary care doctor but will be calling to try to gain an appointment so that my second dose can be monitored.

injection site was swollen and hot and doubled in size also reports fatigue and slight discoloration.

Arm was abnormally sore to the point where it was all the way down my shoulder into my collar bone. About 24 hours after the 2nd dose, I noticed the area around my left collar bone was swollen . The area is painful to touch and contains a lump about the size of a dime. Pain is experienced when I attempt to cross my left arm over my body. Lump and pain still remains 51 hours after vaccination.

Hives; This is a spontaneous report from a contactable other health professional. A 27-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899, Expiry Date: Mar2021, NDC number: 5926710001), via an unspecified route of administration on 30Dec2020 08:11 at a single dose in right bicep (right arm) for COVID-19 immunisation. Medical history included urinary tract infection from 21Dec2020 to Dec2020 which was resolved and fine after the antibiotic, ongoing eczema (had this condition basically her entire life), ongoing sensitive skin (always had pretty sensitive skin). Concomitant medication not reported. The patient previously took nitrofurantoin (MACROBID [NITROFURANTOIN]) from 24Dec2020 to 28Dec2020. The patient experienced hives on 01Jan2021 09:00 (also reported as "got it last Wednesday morning and broke out in hives the next day"). Patient stated, "I have a question to you. I got the Covid Vaccine, the Pfizer Vaccine on Wednesday morning like around 8 o' clock and this morning I woke up and I broke out hives. I didn't know if in two days, I just want to report my symptoms just to make sure everything is okay." The hives were bad on Friday and took Benadryl and Cortisone cream and it is better now. The hives are not worse; not as bad as it was on the first day. She took about 5 Benadryl throughout the first day: 01Jan2021. Over the last few days she has continued to get small breakouts of hives on pretty much every single spot on her body except for her face; the hives seem to kind of take turns in different areas of the body but have not gone away. She has used Hydrocortisone, lotion and Benadryl for the hives. The outcome of the event was recovering. She is both a sonogram technologist as well as the patient. She asked if she should or should not receive the second dose of Pfizer COVID- 19 Vaccine in response to the hives. She is supposed to get second dose on 19Jan2021; unknown if she will or will not change dose scheduling in response to event at this time.

lymphadenopathy; chills; tachycardia; weakness; feeling unwell; injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches; injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches; injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches; fever that reach 101.5F; injection site pain; myalgia in the entire left arm; This is a spontaneous report from a contactable healthcare professional (patient). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were unknown), via an unspecified route of administration on the left arm on 30Dec2020 18:00 at single dose for COVID-19 immunization. Medical history included polycystic ovarian syndrome (PCOS). Patient was diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient was not pregnant at the time for vaccination. Concomitant medication included metformin, ergocalciferol (VIT D), and tretinoin cream. Right after injection, the patient had injection site pain and myalgia in the entire left arm on 30Dec2020. The second day, 31Dec2020, about 19 hours after receiving the vaccine, patient started feeling unwell. The injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches on 30Dec2020. Patient developed a fever that reach 101.5F on 30Dec2020. She also experienced chills, tachycardia, and weakness about 24hours after injection on 31Dec2020. Patient experienced lymphadenopathy during the 3rd (01Jan2021) and 4th day (02Jan2021). Patient recovered with lasting effects (recovered with sequel). TYLENOL was received as treatment for the events except for lymphadenopathy. The reporter considered the events non-serious. Information on the Lot/Batch Number has been requested.

I received high temperature of a 100.1; Muscle aches; muscle pain; Body aches; nausea; I was developing soreness at the injection site of the arm; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899; expiry date: unknown) via an unspecified route of administration, on 31Dec2020 at 12:20, at a single dose, as preventive measure for COVID. The patient has no relevant medical history. There were no concomitant medications. The patient received the vaccine on 31Dec2020 about 12:20. On the same day, midafternoon, patient developed soreness at the injection site of the arm. The following day (01Jan2021), in the morning, she had a high temperature of a 100.1 along with some muscle aches/ muscle pain, body aches, and nausea. Outcome of the events was unknown.

side effects lasted 24 hours. 12 hours after second dose, chills occurred. this was followed by fever and muscle aches. Highest fever was 101.7 F. side effects were bad enough to affect ability to do ADLs and to be able to go to work. Swollen lymph node in left clavicle since first dose got bigger and firmer. since symptoms have resolved swollen lymph node still there.

Nausea, vomiting, diarrhea, fever, chills, dizziness, headache, muscle and joint aches, pain at the injection site, dry mouth, shortness of breath. Took ibuprofen and Tylenol.

Fine for ~6-9 hours post injection. But then immediate fever (103F), body ache, extreme joint pain and a feeling of something eating away in my bones, chills, bruised/swollen/pain in left arm (injection spot), fever, fatigue, headache, light cough for 5 straight days. Not able to do normal activities. Took Tylenol and ice pack to alleviate fever. The day after injection, body fell so weak that my body acquired another viral infection (very unusual). No shortness of breath. Eating/drinking/appetite fine. No loss of taste/smell. I am exactly 1 week from the injection. No fever, just light headache. Able to resume normal activities but gets fatigued fairly quickly (after 3 hours). I am very active and work out 2 hours every day, but may not be able to do strenuous activity/exercise for some time... I was symptomatic covid last year in April 2019. This was very similar experience but an extremely debilitating, more intense version of the covid that I had. ***I am unsure if I should proceed with the second dose due to a very severe reaction to the first dose***

Medication was administered subcutaneous not intramuscular. Cellulitis occurred, site was warm, red, swollen, painful and hard. Was prescribed keflex by ID DR on Saturday, 1/9/2020. Site continued to grow until Monday, 1/12/2020.

Once I receive the shot; my arm became red. I start seeing red bumps around the area I receive the shot. My next day I had itchy bumps on both arms. By the 3rd day my whole body was covered with bumps. That lasted for a week.

I had redness injection site and little rash. I notice little red spots. The 2nd day I receive bumps on both arm, which was very itchy. The 3rd day my whole body was fill with the bumps. The bumps lasted for a week.

Tachycardia and palpitations within 5 minutes of administration. Lasted for about 5 minutes then resolved. Approximately 20 mins after administration of vaccine minor swelling of the throat and limited rash on the throat present. 50 mg oral Benadryl taken an hour after vaccination.

Patient complained of itching dermatitis throughout torso and face with visible hives. Patient complained of throat "feeling funny". Patient immediately transported by wheelchair 300 ft to ED.

Pfizer-BioNTech COVID-19 Vaccine EUA: 1. Injection site tenderness x 2-3 days, no treatment 2. Fatigue, severe headache, muscle pain, fever x 8-10 hours (started about 10 hours after getting the vaccine), Tylenol

immediate after this vaccination for COVID-19 prevention, pt. developed lightheaded and dizziness she says. on questioning if BP was checked, she said BP was not checked. Denies ever getting lightheaded or dizziness with other types of vaccinations or immunizations so probable not vasovagal. Headaches she also reported arm aching at this vaccination site. initially said in 1/2 hour later she says 2 hours. She looked at the vaccination site on her arm for first time 8 hours after this vaccination. Found redness and blisters first time treated with diphenhydramine 5 mg. barely move arm next day. swelling arm lasted 2 days. photos of arm vaccination site she sent were reviewed. had video visit with Family Medicine Physician and later with video visit with Allergy Physician

developed hives on arm along with fever, chills and muscle aches. Self treated and symptoms resolved

Urticaria; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK5730) intramuscular on 18Dec2020 at a single dose on the left arm as vaccine. Medical history was not reported. There were no concomitant medications (did not receive other vaccines within four weeks to the COVID vaccine and did not receive other medications within two weeks of vaccination). The patient had no known allergies to medications, food, or other products. The patient was vaccinated in a hospital (facility where the most recent COVID-19 vaccine was administered). The patient experienced urticaria on 18Dec2020 assessed as non-serious which did not result in death, not life threatening, did not caused/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. She was not pregnant at the time of vaccination. She was not diagnosed with COVID-19 prior to vaccination. She had Covid tested post vaccination (had been tested for COVID-19 since vaccination)- nasal swab result negative on 31Dec2020. Treatment for the event included Benadryl. The outcome of the event was recovered. No follow-up attempts are possible. No further information is expected.

body aches; headache; fever; body chills; wasn't able to sleep; pain throughout her arm/injection site was extremely sore; This is a spontaneous report from a contactable healthcare professional. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number ek9231/expiration date unknown), dose number 1, via an unspecified route of administration on 03Jan2021 14:15 at a single dose on the left arm for COVID-19 immunization. Medical history included migraines. Concomitant medications were not reported. The patient was fine the day she got the vaccine, but when it came to the night of 03Jan2021, she wasn't able to sleep due to the pain throughout her arm. On 04Jan2021 04:00, she woke up with a headache that was intense, fever, and body chills. The injection site was extremely sore to the point where she took some Tylenol and slept it off. On 05Jan2021, she felt a lot better, but still with mild body aches. The patient was not diagnosed with COVID-19 prior to vaccination. She was not tested for COVID-19 since the vaccination. The vaccine was received in a hospital. No other vaccines were given in four weeks. The outcome of the events was not recovered for body aches, and recovering for the other events.

left eyelid swollen; she sweat a lot; rash on head around bump on her left; swollen lymph nodes on neck left side/right side/swollen lymph node on collar bone right side; pain in left side of her face; Fever; feel tired; felt like her body was hot; bump on head on left side; face was numb on left side; pimples to left eyebrows; possibly has shingles; This is a spontaneous report from a contactable consumer (patient). A 27 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140) at her right arm at single dose for COVID-19 immunization on 29Dec2020. Relevant history included she had UTI, acne and dandruff which she had before the vaccine. Concomitant drug included clomifene citrate (CLOMID) since 30Dec2020 (5 days regimen). Past drug included she was taking Ampicillin 25mg prior to vaccine (last dose 2 days before vaccine). The patient experienced face was numb on left side since 02Jan2021. The patient also experienced pain in left side of her face, swollen lymph node on neck left side/neck right side, feel tired, felt like her body was hot, bump on head on left side, rash on head around bump on her left and fever since 03Jan2020. She took medication for fever. She felt good when take Motrin or Tylenol and then it came back again being tired. Then, the patient stated she sweat a lot since 04Jan2021, she had swollen lymph node on collar bone right side since 05Jan2021. The had left eyelid swollen since 06Jan2021. The patient also experienced pimples to left eyebrows that started Saturday or Sunday and possibly had shingles since unknown date in Jan2021. The patient went to the doctor because the doctor suggested that she had shingles and she had the shingles test on 06Jan2021, while she had not gotten the results back yet. The outcome of event Fever was recovered with sequel on 06Jan2021. Outcome of event possibly had shingles was unknown. The outcome of event she sweat a lot was Resolving. The outcome of other events was not resolved. The events pain in left side of her face, swollen lymph node on neck left side, rash on head around bump on her left, left eyelid swollen and pimples to left eyebrows was worsened.

PATIENT WAS WORKING HER SHIFT AT HOSPITAL ON 1/13/21 BUT WAS TOLD TO STOP WORKING AND VISIT THE COVID CLINIC WHEN HER REACTIONS STARTED. SHE APPEARED FLUSHED, AND WAS DEVELOPING A RASH ON BOTH HER ARMS, ITCHING. HER INJECTION SITE WAS RED AS WELL AS THE SURROUNDING AREA, ABOUT 1INCH IN DIAMETER. SHE REPORTS NO DIFFICULTIES BREATHING, BUT SOUNDED LIKE SHE WAS BREATHING A LITTLE ON THE HEAVIER SIDE. SHE SAID THAT IT FEELS LIKE THE LOWER HALF OF HER THROAT IS A BIT BIG AND STARTING TO SWELL. SHE WAS WALKED TO ED BY ANOTHER NURSE. ED MD FELT THE INJECTION SITE WAS INFECTED. PATIENT RECEIVED ANTIBIOTICS AND BENADRYL FOR THE ITCHING.

Within 8 hours of receiving dose #2 of COVID19 Pfizer, I experienced pain/stiffness at injection site, body chills, body aches and a fever of 102 F. Symptoms subsided after Motrin was administered (in about an additional 8 hours to recover fever). Body aches, pain at injection site and lingering headache still present 24 hours after vaccination.

Muscle tension all over body especially in neck, back, low back, and arms. Intense headache and fatigue. Sore injection site, tender to the touch. Moments of Dizziness and zoning out.

rash/getting this rash on my face and everywhere/rash and it is breaking out her face and now it is all over; a lot of muscle pain; could not sleep; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left deltoid on 24Dec2020 09:30 at single dose for preventative. Medical history included none. There were no concomitant medications. The patient previously took influenza vaccine (FLU) for immunization and experienced sick (Flu shot if it contains egg she gets really sick). Patient reported experiencing a rash 2 weeks on 06Jan2021 after getting her first dose of the vaccine. Caller stated ''I'm concerned because I'm getting this rash on my face and everywhere and I'm due for my booster on 13Jan2021." Caller questioned if others had reported this. She had a lot of muscle pain on 24Dec2020 and could not sleep from the pain in Dec2020. Reports the pain is gone now and lasted till 28Dec2020. She has a rash and it is breaking out her face and now it is all over. States nothing has changed and the vaccine was the only new thing. States the rash started two weeks since she got the vaccine. Vaccination facility type was Hospital. Vaccine administered at military facility was No. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. AE not require a visit to emergency room. Therapeutic measures were taken as a result of rash/getting this rash on my face and everywhere/rash and it is breaking out her face and now it is all over (Doctor ordered steroids for her today she is a CNA). The outcome of the event a lot of muscle pain was recovered on 28Dec2020. The outcome of the event rash/getting this rash on my face and everywhere/rash and it is breaking out her face and now it is all over was not recovered. The outcome of the event could not sleep was unknown. Information about lot/batch has been requested.

After receiving my second dose of the Pfizer COVID-19 Vaccine on the morning of 1/13/21, I had arm soreness at the injection site. Later in the day, I experienced fatigue, which progressed to body chills and aches. Overnight, I developed a fever of 101.5 F. Fever was managed with ibuprofen taken throughout the following day, 1/13/21. On 1/13/21 at night, I had another fever of 101.6 F but did not taken any antipyretics before bed. On the morning 1/14/21 body aches, body chills, and fevers were resolved without antipyretics. Arm soreness still present on 1/14/21.

My injection was at 4:08 pm on 1/13/21. I woke up from a dead sleep at 2:30am on 1/14/21 and started vomiting for about 20-25 minutes. Also muscle pain at injection site.

Patient reported having a rash/itching hands and feet about 2days after the vaccine. Took Benadryl 4 times a day and resolved two days later. was told to contact primary care physician before getting the second dose

Hives on chest, neck, and face, headache, diaphoresis five min after COVID vaccine A & O x4, ambulates. Administered Benadryl 50mg PO. symptoms persist after 20min. Called 911, evaluated and transported to Emergency Dept.

injection site pain; This is a spontaneous report from a non-contactable pharmacist (patient). A 27-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK5730, expiry: unknown), via an unspecified route of administration on 17Dec2020 12:00 at single dose (Left Arm) for COVID-19 immunization. Medical history reported as none. Patient had no known allergies. Patient is not pregnant. The patient's concomitant medications were not reported. Other medications within 2 weeks of vaccination was reported as oral contraceptives. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Only adverse event related to first dose was injection site pain from an unspecified date. The outcome of the event was unknown. The events were reported as non-serious. No follow-up attempts are possible. No further information is expected.

redness and mild swelling at injection site; redness and mild swelling at injection site; sore arm; This is a spontaneous report from a contactable healthcare professional (patient). A 27-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 5730), via intramuscular route of administration on the left arm on 18Dec2020 17:15, then the second dose via an unspecified route of administration on the left arm on 07Jan2021, both at single dose for COVID-19 immunization administered at hospital facility. Medical history included asthma, anxiety, vitamin d deficiency, eczema and rosacea, and known allergies: nickel and latex. Concomitant medications included influenza vaccine (FLU) on 11Nov2020 received within 4 weeks prior to the COVID vaccine; minocycline, cetirizine hydrochloride (ZYRTEC), ethinylestradiol, norgestrel (CRYSELLE), colecalciferol (VITAMIN D) , calcium, and vitamin b complex received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced redness and mild swelling at injection site, sore arm on 19Dec2020. The events were reported as non-serious and no treatment was given. The patient underwent COVID test/ nasal swab: negative on 24Nov2020. The outcome of the events was recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.

After about 2 hours l arm felt tight and swollen, woke up in the night with severe arm pain, could not lift arm to dress pain continued to increase, felt like a circulation issue = numb, cold, limp contacted employee heatl

After administering the first dose, patient became itchy and blotchy all over body. At 11:04am gave patient Benadryl 50mg. By 11:12am redness was going away.

Left arm unusually tight and swollen about 2 hours after injection. Woke up that night in severe pain. Unable to life arm to dress next morning. Increasing pain, felt like a circulation problem - cold, numb, limp used ice and tylenol and aleve, day two slightly better

hives after first shot; This is a spontaneous report from a non-contactable healthcare professional (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) solution for injection, via an unspecified route of administration, the first dose on 15Dec2020 (lot number: EH9899) at a single dose, then the second dose on 08Jan2021 (lot number: EK9231) at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant. The patient experienced hives after first shot on 15Dec2020. No treatment received. Outcome of the event was recovered. No follow-up attempts are possible. No further information is expected.

Vaccinated at 8:55am, Per Nurse Practitioner note patient started experiencing itching upper chest, medicated with Benadryl P.O., started with throat itching, medicated with Benadryl IM, EPI IM, EMS called, placed on O2, diminished breath sounds bases, slight stridor, EPI IM, Solumedrol IM, EMS transported to local ED. Patient called NP later in day and said she was admitted to the hospital.

Vaccination was on Wednesday: about a half hour after vaccine, I experiences increased heart rate, vision going black like I was going to pass out, it passed in about 5-10minutes of laying down; also had metallic taste in mouth the rest of that day. Thursday I just felt red, itchy, swollen L arm due to vaccination site. Friday morning my bottom lip was severely swollen with numbness and tingling. It went down by the next day and after taking Benadryl. I have not had an allergic reaction to anything in my life before. Was instructed to not get second vaccine as I may have a more increased reaction to it.

When I went to get the shot, I had a firm bump with what looked like a white head on my left arm from the first shot. When she injected the 2nd dose, the bump was painful and grew twice in size on my arm and started bleeding. The technician rubbed the area for a fews minutes and the swelling went down. The bump went down, but the whole day, I felt a little sick. At around 7pm, I felt feverish, with muscle aches and chills. My skin was sensitive to touch, I felt nauseous, and I could barely walk. The bottom of my left eyelid also became a little swollen. The symptoms resolved the next morning.

Received shot Wednesday night, developed arm soreness and mild flu like symptoms on left side of my body and facial paresthesias on the left side of my face. Twelve hours later, after waking up those same symptoms were only on the right side of my body. Friday morning, mostly normal physically just with some overall fatigue. Friday afternoon I started to get hives on my chest and overnight into Saturday they were on my lower back, sides, and legs. I took 50 mg of Benadryl every 6-12 hours until Monday mid-day when Benadryl was not helping reduce the hives and so I had full body hives. I did try an drugstore cortisone cream which did not help. Sought treatment at an urgent care as I was feeling anxious and could not control the itching. I and was diagnosed with likely allergic reaction to the covid-19 vaccine.

Arm pit sore - to injection site, warm to touch, red area, tender to touch, swollen denies any fever Started on abx - cephalexin

Significant arm soreness, limited muscle rotation for 3 days. Redness around injection site and redness of bandaid mark 3 days later with multiple washes.

Fifteen minutes following injection, the left arm broke out in hives and had numbness and tingling. Then I became dizzy and pale. I was laid down and vital signs were taken. My heart rate was in the 110s and 120s and stayed elevated for about four hours. The hives resolved and did not spread to the bilateral arm or anywhere else. The following two days I felt incredibly weak and had urinary frequency. I was told to go to the hospital by the health clinic staff but I declined.

About 10-15 minutes after vaccination, patient reported that she was feeling dizzy and was breaking out in a rash. Upon examination, a maculopapular rash was observed on upper chest and arms. No localized symptoms at injection site were reported. No breathing abnormality was reported. Patient was placed under further observation and vitals were taken by RN at facility (BP: ~113/100, HR: 105). Patient was observed for another 15 minutes, patient reported her dizziness was still present, rash was not worse at this time. No breathing abnormality was reported at this time either. Medical services (which were called for a different patient) also evaluated this patient and the patient was then taken to local ED for further evaluation.

tingle in throat; Severe left arm pain; Dizziness; weakness; migraine; This is spontaneous report from a non-contactable other healthcare professional (patient). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration (left arm) on 01Jan2021 10:45 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. No known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that immediately after receiving vaccine (01Jan2021), the patient felt tingle in throat, severe left arm pain, dizziness, weakness, and migraine. There was no treatment received for the adverse event. The outcome of events was not recovered. The patient has not been tested for COVID-19 since the vaccination. This case is non-serious. No follow-up attempts are possible. No further information is expected.

injection site was swollen; headache; chills; nausea; arm was sore for a few days; muscle pain; weakness; fever; This is a spontaneous report from a contactable nurse. A 27-year-old female patient received receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: EH9899, intramuscular, in the left arm from 16Dec2020 17:45 at SINGLE DOSE for COVID-19 immunization. Medical history included asthma, Hypothyroid, HSV (Herpes simplex virus) and Penicillin allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient was not pregnant. Concomitant medication included levothyroxine sodium (SYNTHROID), cetirizine hydrochloride (ZYRTEC), and fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA). On 17Dec2020 10:00, it was reported that the injection site was swollen for about a week. Her arm was sore for a few days and had muscle pain and weakness which also started on 17Dec2020 at 10:00. She also had headache, fever, chills, and nausea 17Dec2020 10:00. The outcome of events was reported as recovered. No treatment was received/ required due to events. No follow-up attempts possible. No further information expected. Information on the batch/lot number has been obtained.

Patient had onset of symptoms within five minutes of the vaccination, felt rapid heart rate and dizzy. Had patient lay down, monitored VS every 10 minutes. 1750 - BP 114/70, P 85, R18, O2 100 1800 BP 127/65, P78, R16, O2 100. Drinking water. After 10 minutes heart rate felt better but c/o itching, flushed chest. Gave oral Benadryl 25mg liquid. VS 1810 BP 120/67, P 70, R 16, O2 100%. VS at 1830 BP 115/61, P70, R 15, O2100%

I had side effects (fevers, myalgias, headaches) the day after. However, starting Saturday 1/9 I began having urticaria all over my body. I took Benadryl 4 times over the course of the day, and the rash goes away but comes back. Went to Urgent Care on Sunday. Advised to take Benadryl and Pepcid

1410 Client became light headed and reported to obs desk. Unassisted descent to floor upon turning to go to a 30 min obs seat. Did not strike head, sat on buttocks and propped self with left arm; No medical Hx. BP 140/100 P 96 R 12 SpO2 100%; LOC A&O x3, did not lose consciousness; skin warm pink and sweaty; hot at back of neck; HR regular; Resps unlabored; Lungs clear; assisted to a supine on floor and legs elevated; ice pack for comfort; EMS notified 1420 BP 152/104 P 70 R 12 SpO2 99% Resps continued unlabored; EMS arrived; Handoff report given; EMS assessed; client sitting; ; client offered transport to local ED and declined 1430 Client moved back into chair; BP 136/94 P 94 R 12 SpO2 99% 1440 Client stated she was starting to feel light headed again. Moved to floor and legs elevated again. BP 140/90 P 87 R10; Resps unlabored; A&O x3; skin cool pink dry; 1445 BP 136/108 P 85 R 10 ; continues supine with legs elevated; requested that client find someone to drive her home rather than drive self; client contacting boyfriend 1450 BP 140/108 Client states she feels fine but would like to remain on the floor sitting up. 1500 Client moved to chair for further observation; VS assessment discontinued 1530 Client remains in obs and waiting for ride

Patient reported swelling of lymph nodes in armpit, inflamed injections site, pain. Recommended icing the area, take diphenhydramine and some Tylenol and/or ibuprofen for pain and inflammation.

I was asymptomatic for about 6.5 hours after the vaccine was given. At about 6pm on the day I received the vaccine I noticed some injection site tenderness, minimal swelling; has been present since. Symptoms are very mild. I started having chills and hot flashes intermittently, more hot flashes than chills, have been present since 6pm yesterday. About 9pm I had a headache, muscle aches, joint pain as well. I felt feverish but temperature was 98.6F. I also noticed some axial lymph node swelling as well on the Left side where I received the vaccine. Tender to touch, not too painful though. Since received the vaccine I have had intermittent dizzy spells as well all throughout the day. I decided to go to sleep at 10:30pm and all night I tossed and turned with a headache and hot flashes. I woke up at 7:30am and was so stiff I could barely get out of bed. I called into work as I could not stand up without have dizziness. All day so far I have had dizziness upon standing, headache, myalgia, arthralgias, hot flashes/felt feverish, swollen axial lymph nodes and all I have wanted to do today is sleep. I took a nap and when I woke up I had been sleeping for 6 hours. I finally was able to get up and drink a 32ounce cup of water and take some ibuprofen. Ate some cereal. I still have a headache and dizziness upon standing that limit my ability to do normal daily functions.

First started off with a cold feeling around injection site. Around 11:30 at night I felt muscle aches in my calves. 30 minutes later my legs were having severe muscle aches and joint pain in my ankles. I was having cold chills and aches the whole night along with sweating. On 1/20/2021 (the next day) the muscle aches, chills, and joint pain continued through the whole day. I was nauseous at times and did not have an appetite. Around 5 o clock I felt some relief with my leg pain but it started again around 9 o clock. I continued switching Tylenol extra strength and ibuprofen. I went to bed on 1/20 at midnight with little leg pain but major neck and back aches. I did not have cold chills through the night or sweating. Today (1/21/2021) leg pain is near gone, but joint pain is still there in my left ankle and knee. My legs feel heavy and strange and is causing me to walk slowly because I feel like my legs are very fatigued and off balance. I have had neck and back aches all day. I have not had chills today

Chills, fever, body aches, headache started about 12 hours after injection. About 24 hours after injection I developed a rash and swollen lymph nodes on the arm the shot was given to me

Rash on upper body; This is a spontaneous report from a contactable healthcare professional (patient). A 27-year-old female patient received the first dose of BNT162B2, intramuscularly in right arm on 08Jan2021 15:30 at single dose for COVID-19 immunization. Medical history was none. Concomitant medications were unspecified. On 10Jan2021 15:00, patient experienced rash on upper body. Treatment was not received for this event. Outcome of the event was unknown. Information on the lot/batch number has been requested.

30 minutes after vaccine pt developed rash on arms and had tingling in right arm. No other symptoms. Gave 1 dose of 50mg benedryl and within 15 minutes the tingling had stopped and the rash went down. Monitored for 30 minutes and the pt was then released.

Fever (103 lasting a day and a half); Nausea; Chills; Muscle aches and soreness; Malaise; Lymphadenopathy; Arm/under arm/pec soreness in vaccine arm; Fatigue; Sore throat; Dry cough; recevied first dose on 21Dec2020 10:15, then received second dose on 07Jan2021 07:45; recevied first dose on 21Dec2020 10:15, then received second dose on 07Jan2021 07:45; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via intramuscular on 07Jan2021 07:45 at single dose in left arm for covid-19 immunization. The patient had no medical history and no known allergies. Concomitant medication in two weeks included birth control. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via intramuscular on 21Dec2020 10:15 at single dose in left arm for covid-19 immunization. The patient had no other vaccine in four weeks. No covid tested post vaccination. The patient experienced fever (103 lasting a day and a half), nausea, chills, muscle aches and soreness, malaise, lymphadenopathy and soreness, arm/under arm/pec soreness in vaccine arm, fatigue, sore throat, dry cough on 07Jan2021 19:00. The patient did not receive any treatment for these events. The outcome of the events fever (103 lasting a day and a half), nausea, chills, muscle aches and soreness, malaise, lymphadenopathy and soreness, arm/under arm/pec soreness in vaccine arm, fatigue, sore throat, dry cough was recovered in Jan2021. Information on the lot/batch number has been requested.

Pfizer-BioNTech COVID-19 Vaccine EUA: Approximately three days after vaccine administration patient developed itching and redness of face and body. Went to urgent care and prescribed hydroxyzine which patient took and immediately relieved symptoms. No other medications administered and no other symptoms reported.

Patient received vaccine on 01/06/2021 and developed a diffuse rash on 01/20/2021. Rash started on the chest and then spread to the bilateral arms, bilateral legs, and her back. Her face, palms, and soles are spared. Rash is mildly pruritic and not painful. Patient reports at the time the rash started she had a cough and SOB for 1 hour that has resolved and not returned. Patient has been taken OTC Benadryl PRN every 6-8 hours since the rash presented. Patient presented to Clinic for evaluation on 01/22/2021.

Patient developed diffuse rash on 01/20/2021, 2 weeks after COVID-19 vaccine administered on 0/06/2021. Rash erythematous and raised with no hives. Rash started on chest and has spread to bilateral arms, bilateral legs, and back. Face, palms, and soles spared. Reports cough and shortness of breath for an hour when rash first appeared that resolved and has no returned. Since rash has started has taken OTC Benadryl every 6-8 hours. Patient presented on 01/22/2021 for evaluation of the rash.

Approx 3 -5 minutes after vaccine -redness and hives on both arms, chest, and face. Approximately 10 minutes after vaccine- cough, shortness of breath, tongue itchy, lips swelling. Epi pen in L thigh, 50 mg benedryl IM in R deltoid. Brought to emergency room, 1 liter normal saline, pepcid, solu-medrol, 25mg benadryl IV. D/c to home around noon. 1/22/2020- secondary anaphylactic reaction at 945am. Epi pen to r thigh, 50mg PO benadryl, 20mg prednisone. Drove to hospital ER received 1 liter of normal saline, pepcid, 25mg benadryl IV, 40mg prednisone. D/C at 3pm on prednisone taper.

I received my vaccine yesterday. I waited at the location for 15 minutes with no issues. After about 20 minutes, I developed a burning sensation at the injection site. Approximately 30 minutes following the vaccine, I began experiencing an intense itching and hives of my opposite forearm. Then shortly after, my shins and front of ankles started itching. I began getting little bumps with an itch to several other areas of my body, also including redness and itchiness of one side of my face. At about 40 minutes, I also experienced a cold sensation felt at the injection site, almost like what it feels like after removing an ice cube from the skin. The itching of my skin on several areas of my body persisted for about an hour and a half. The welts and itchiness almost completely subsided at about the 2 hour mark. I did take two benedryls once I got home which was about an hour and a half after the injection. Today, the following day after injection, the bumps and itchiness are still no longer present. I have been experiencing a very sore arm at injection site and extreme exhaustion today though.

Had itching at site immediately rash above site developed later in the day. About 10 minutes after injection developed nausea then felt very hot became clammy and sweaty. Felt lightheaded became pale had to played down on the ground.

Within 5-10 minutes of receiving the vaccine my heart starting racing a little bit, I got a little light headed, and had a weird taste in my mouth. The morning after my vaccine (1/22/2021) the Injection site of the vaccine is swollen, hot to the touch, and red/hard. The following day (1/22/2021) around 3:45 pm I broke out in a rash on my face and neck

Nausea (2-3 days) Constant headache Swelling in injection site Redness at injection site Feeling unwell

Two hours after the vaccine was given, I developed a headache and the injection site was sore. I treated it with ibuprofen. Approximately 48 hours after the vaccine was given, I experienced a sore throat and fatigue that has lasted for two days and counting.

sweating; chills; fever; major fatigue; Major hair loss starting 1.5 days following the vaccination; This is a spontaneous report from a contactable other health care professional. A 27-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL0142), intramuscular on 12Jan2021 16:30 at SINGLE DOSE at Arm Left for covid-19 immunisation. Medical history included covid-19; covid prior vaccination: yes. Concomitant medication included escitalopram oxalate (LEXAPRO). Major hair loss starting 1.5 days following the vaccination on an unspecified date in Jan2021, in addition to sweating, chills, fever, and major fatigue on 13Jan2021 22:30. The patient did not receive treatment for the events. The outcome of the events was not recovered.

Red rash on my face about 24 hours after initial dose- went away with Benadryl Rash was itchy and blotchy

Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; Dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site, chills. Dizziness and headache persisting from time to time; This is a spontaneous report from a contactable other hcp. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:ek9x31 and expiry date unknown), intramuscular on the right arm on 05Jan2021 11:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included pneumonia, bronchitis and sinusitis from an unknown date and unknown if ongoing. Concomitant medication included ethinylestradiol, norgestimate (TRI-SPRINTEC), fish oil (FISH OIL) and olly womans multivitamin. The patient experienced dizziness, fever, sore/dry throat, severe headache, muscle aches, swollen lymph nodes, sore arm at injection site and chills on 06Jan2021. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 01Jan2021. Therapeutic measures were taken as a result of the events. The patient was advised to rest for 2 days and take Tylenol. The outcome of the events was recovered with sequelae.

Previously enlarged lymph node (after first COVID 19 vaccine) became larger and red for 3 days. It then went back down to the size it was after the first injection.

swelling at injection site; pain, itching, redness, warmth at injection site; pain, itching, redness, warmth at injection site; pain, itching, redness, warmth at injection site; pain, itching, redness, warmth at injection site; body aches; fatigue; fever 100.2; This is a spontaneous report from a contactable Nurse. A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3249), intramuscular on 13Jan2021 10:45 at single dose for covid-19 immunisation. Vaccine location was left arm. Medical history included covid-19. Historical vaccine included first dose of BNT162B2 lot number EK5730 on 22Dec2020 10:15 AM. Concomitant medications included multivitamins, ascorbic acid (VITAMIN C), cetirizine hydrochloride (ZYRTEC). The patient experienced body aches on 14Jan2021 05:00, fatigue on 14Jan2021 05:00, fever 100.2 on 14Jan2021 05:00, pain, itching, redness, warmth at injection site on 15Jan2021. The patient underwent lab tests and procedures which included body temperature: 100.2 on 14Jan2021, and 99.8 on 15Jan2021. No treatment received. The events recovered in Jan2021.

Local skin allergic reaction at the injection site; Swelling (about the size of a quarter) at the injection site; Red dots (about the size of a pencil eraser) that appeared around the injection site; some spots around the area approximately the size of pencil erasers; This is a spontaneous report from a contactable pharmacist (patient). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3302), intramuscular in the left upper deltoid muscle, on 13Jan2021 at 10:30, at a single dose, for COVID-19 vaccination. The patient had no medical history and concomitant medications. On 13Jan2021, the patient received first dose of vaccine and immediately (about 5 minutes after she received the vaccine at 10:35) developed non-severe local skin allergic reaction and swelling at the injection site, and some spots around the area approximately the size of pencil erasers. The patient had swelling (about the size of a quarter) at the injection site, along with red dots (about the size of a pencil eraser) that appeared around the injection site. The patient's vital signs were normal, her breathing was fine, and she had no swelling in her throat or lips. The patient took diphenhydramine hydrochloride (BENADRYL) 25 mg tablet, and a minute or two after taking the diphenhydramine hydrochloride tablet, all the symptoms went away. The patient was calling to see if she should receive the second dose of the vaccine. The patient asked if she should get the second COVID-19 vaccine dose, based on her adverse reactions after receiving the first dose. The patient recovered from the events on 13Jan2021.

While in monitoring area after receiving vaccination client reported hoarse voice, redness, swelling, and tingling of tongue and lips. Redness was in face, chest and right arm. Client denied difficulty breathing or throat tightness. Client reported at this time "significant hx of anaphylactic reaction." This was not noted clearly on screening form signed by client. Client given 50 mg Benadryl per standing order due to symptoms. Epinephrine was not given. 911 was called. Client vitals remained stable with slightly elevated blood pressure ate 140/102. EMS arrived before repeat vitals were taken. Lung sounds were clear and equal bilaterally. Report was given to EMS and care transferred.

Injection sight and left arm pain started immediately. Nausea started around 10:20am, increasing as time passed, started hot flashes , cold flashes and shakes around 11am, right kidney (?) area on back started to hurt around 11:30am pain increasing as well. All persistent until about 5:30pm where the kidney (?) pain subdued followed by the hot and cold flashes around 7pm. Nausea and shakes passed by 1/30/21 am after I woke up. Full Left arm pain continued all day 1/30/21.

Patient sitting in chair of observation area. Suddenly felt dizzy. Observation staff RN brought patient to triage. Patient states she felt dizzy. Lightheaded, nauseated, started vomiting, vomited two times. Slightly diaphoretic. She is warm and dry BP elevated. Patient started to scratch back, lower and mid back. noted with scattered raised red rash. Patient drowsy and altered mental state gave Benadryl. Patient to triage cot, cold pack applied V.S and N.S. measured. Charge nurse present. Benadryl 50mg IM given per protocol. EMS activated. report given to paramedic crew. No further vomiting. V.S.S. SR on monitor O2 sat 99%. Remains orientated to name, place and date. Cannot open her phone or recall family emergency number. Patient sent to hospital with EMS.

?Pfizer-BioNTech COVID-19 Vaccine EUA? Pt had red streaking to arm near injection site approximately 10 minutes after injection, then also had chest tightness and felt like her voice had changed. Was given 50mg of benadryl by EMS with near immediate improvement of her symptoms but pt referred to ED. Pt arrived at ED and felt improved, no redness noted to site, no hives or rash noted on exam. Discharged home

vaccine administration error- left deltoid injection site bleeding moderately immediately following administration, the bleeding stopped with approx 30 seconds of pressure to site. No other adverse reactions. Evaluated by the medical provider at the site and injection appeared to be in the correct area.

I started breaking out in hives/rash on January 27th at church. I was itching all over. I took a benadryl to help. Since then I have continued to break out in spurts. The site will start itching on my body and not stop until I itch it, then it goes away and pops up somewhere else. I have not changed laundry detergent, eating habits or environments. The only thing new to me would be the vaccine. with it being almost 8 days onset from vaccine, I didn't think that would be the problem. I can't figure it out though. I spoke with Doctor this morning and she said it was best to report because it could be an adverse reaction.

Skin feels like she rubbed icy hot all over her body /it feel like her face is on fire /She felt like she was running a fever but was not. She was hot and cold during the night; it burns; felt hot and cold; This is a spontaneous report from a contactable consumer (patient). A 27-years-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , intramuscular on 17Jan2021 at single dose at left arm for covid-19 immunisation . Medical history reported as none. There were no concomitant medications. On 17Jan2021, the patient experienced skin feels like she rubbed icy hot all over her body, like if she scratched or touch it, it burns. There is no redness or rash. Her work just sent her home because she is required to wear an N95 mask. Her breath against the mask makes it feel like her face is on fire and she cannot wear it. She felt like she was running a fever but was not. She was hot and cold during the night, but her temperature was 98 degrees Fahrenheit. She just took Benadryl and they sent her home. The outcome of events was not recovered. No other vaccine in four weeks; No covid prior vaccination. Information on lot/batch number has been requested.

two inches of redness and swelling at the injection site that is tender to touch; two inches of redness and swelling at the injection site that is tender to touch; two inches of redness and swelling at the injection site that is tender to touch; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 13Jan2021 at 16:45 at a single dose on the left arm for COVID-19 immunization. The patient's medical history was reported as none. The patient has no known allergies. Concomitant medication included topiramate (TOPAMAX). The patient was not diagnosed with COVID-19 prior to vaccination. On 15Jan2021, the patient had two inches of redness and swelling at the injection site that is tender to touch. The patient did not receive any treatment for the reported events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was unknown. Information on the lot/batch number has been requested.

the patient felt itchy; flushed; This is a spontaneous report from a contactable pharmacist. A 27-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), intramuscular in left arm on 10Jan2021 at single dose for COVID-19 immunization; and diphenhydramine hcl, via an unspecified route of administration from an unspecified date at unknown dose for premedication. Medical history was reported as none. The patient's concomitant medications were not reported. The patient previously had first dose of BNT162B2, lot number: EL0140, via intramuscular in left arm on 20Dec2020 at single dose for COVID-19 immunization and experienced itching. The patient was not pregnant. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was pre-medicated with diphenhydramine prior to the second dose of the COVID-19 vaccine. 9 minutes after the vaccination on 10Jan2021, the patient felt itchy and flushed then received oral dexamethasone as treatment for the events. The patient was sent out with oral dexamethasone home. The outcome of the events was recovering. The action taken in response to diphenhydramine hcl for the events was unknown.

Moderate rash for 24 hours, headache for 24 hours and fever for 48 hours along with nausea, additional notes not sure if rash is due to shrimp allergy

All over body hives with severe itchiness, medicated with Benadryl, took 2 doses of Benadryl and still feeling itchiness and hives. Symptoms started around 10 am and lasted all day

Scattered Diffuse erythematous plaques ~ 5 days after receiving second Pfizer vaccine + with systemic body aches. Treated with topic steroid and PO steroids

Fever 99.9; body aches; Injection site tenderness, swelling, redness x 10 days; Injection site tenderness, swelling, redness x 10 days; Injection site tenderness, swelling, redness x 10 days; This is a spontaneous report from a contactable nurse (patient). A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) via an unspecified route of administration at left arm, on 22Dec2020 10:15 at single dose for covid-19 immunisation. Medical history included having COVID prior vaccination. Patient has no known allergies. Patient is not pregnant. Concomitant medications included cetirizine hydrochloride (ZYRTEC), vitamins nos (MULTIVITAMIN). Patient did not receive other vaccine in four weeks. Patient experienced fever 99.9, body aches, Injection site tenderness, swelling, redness x 10 days, all on 23Dec2020 08:00. No treatment received for events. Patient did not test COVID post vaccination. Outcome of the events was recovered.

The next day following the vaccine, I experienced muscle aches, headache, fatigue, febrile temp before taking antifebrile medication at 100.8 F. At the site of injection on my left arm there was a red mark and slight swelling, left arm felt weak and sore. Overall sense of unwell lasted for two days.

Pain at injection site; muscle pain; fatigue; dizziness; This is a spontaneous report from a contactable healthcare professional (patient). A 27-year-old female patient (unknown if pregnant at the time of vaccination) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration on left arm on 23Jan2021 13:15 at single dose for covid-19 immunisation. Medical history included Migraines with aura, vasovagal syncope, PCOS, environmental allergies/hay fever, eczema. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included cefixime (FLEXERIL), ibuprofen (ADVIL), montelukast sodium (SINGULAIR), cetirizine hydrochloride (ZYRTEC), inositol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced pain at injection site, muscle pain, fatigue, dizziness, all on 23Jan2021 1400. The events were assessed as non-serious. Since the vaccination, the patient has not been tested for COVID-19. No treatment was given for the events. The outcome of the events was recovering.

Muscle sore and itchy around injection site. No redness. EMS evaluated and removed band aid. Had client do arm stretching exercised and felt better.. BP 120/82 P72 O2 98% lung sounds clear

Client upper arms flush red and chest. Is complaining of feeling warm and headache. EMS evaluated Bp122/90, lung sounds clear. Instructed to either see PCP or go to ER. Client called Dermatologist and showed her doctor her chest in between EMS check. Derm. doctor instructed her to take benadryl Client to be driven home by family. Instructed if does not improve with benadryl to go to ER.

Tingling beginning at thumb and pointer finger, progress to forearm and upper arm over 3 days. Swelling began near elbow, redness and pain followed and immobility. Visited ER on 2/3/21 and diagnosed with superficial thrombophlebitis

Within an hour, I was having severe pain in my shoulder. I took off the bandaid and noticed the injection point was way higher than it should have been. I had redness in the area (about 1-1.5 inch diameter) too that I have a picture of to show the injection location. I have limited range of motion, severe pain, and shooting pain down the back of my arm. I am unable to use my arm or lift anything that has any weight to it.

Rash on inside of elbow on same arm as injection; This is a spontaneous report from a non-contactable consumer report for self. This 27-year-old not pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), via an unspecified route of administration at arm on 20Jan2021 16:00 at single dose for COVID-19 immunization. The patient's medical history and patient's concomitant medications were not reported. The patient experienced rash on inside of elbow on same arm as injection on 22Jan2021. Event recovered on 24Jan2021. No follow-up attempts are possible. No further information is expected.

After second dose pain at injection site; chills; diarrhea; GI upset; unwell feeling; This is a spontaneous report from a contactable Other Health Professional reported for herself. A 27-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), via an unspecified route of administration left arm, on 20Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history reported as none. No reported allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered as at the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient is not pregnant at vaccination time. The patient's concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 30Dec2020 on the left arm. The patient experienced after second dose, pain at injection site, chills, diarrhea, GI upset, and unwell feeling on 20Jan2021 21:00. No treatment was given for the events. Outcome of the events was unknown. The reporter assessed the events as non-serious. Information on the lot/batch number has been requested.

Hives on arms, appeared 10 minutes after injection. No breathing issues. Dosed two 25mg diphenhydramine capsules. Pt had no hives 1 hour later. Told to follow up with emergency department if hives returned

first 3 days after injection she hovered around 98.8 fever. accompanied with chills, intense muscles pain all over, and it moved around. like sometimes she felt like an elephant on her lap., lower backpain , head pain, itching all over on and off. rash on her left arm and all along the inside of her arm all the way down for two days and on third left side of head. Day 3 pain with chewing, numbness on the left side inside the mouth with swallowing, combination of numbness and pain on left cheek. pain on the left side of face, neck cheek and chaw line. the neck was numb to touch and didn't feel cold or hot on left side. popping in her ear and inside mouth like pop rocks. and lots of throbbing in the TMJ joint. I could touch it and i could feel the throbbing in my finger. lasted until day 8 and then resolved slowly a little bit each day. was diagnosed with modified bells paulsey. with sensory involvement and didn't treat with steroids. and able to swallow but it felt numb. FaceTime with the INT to gather this info

Very intense itching all over the top of my scalp; This is a spontaneous report from a contactable consumer reporting for self. This 27-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248) on 20Jan2021 at 9 O'clock in the morning at single dose for COVID-19 immunization. Medical history included anxiety depression. Concomitant medication included escitalopram oxalate (LEXAPRO) for anxiety depression. The patient previously received oxycodone hydrochloride; oxycodone terephthalate; paracetamol (PERCOCET) and experienced intense itching. The patient experienced very intense itching all over the top of her scalp for about an hour (as reported) on 20Jan2021 at 2 O'clock in the afternoon. Patient did not receive any treatment, it did go away on it's own, and only lasted about 2 hours (as reported). The outcome of event was recovered on 20Jan2021.

Patient stated that had an itchy throat and developed a rash through the body. She also reported itchiness through the body.

Rash to face started 2/9/21 evening incontinence of urine, 2/9/21 overnight nausea, stomach pain 2/8/21 daytime/afternoon

Severe eczema flare up on neck (For vaccine 1, which was 20 days earlier, I also had an eczema flare up on my ears)

Three days after both doses of the Pfizer Covid 19 vaccine, I experienced hand pain throughout the night that traveled up my forearms. On a scale from 1-10 the pain was about a 7. After the first dose, the pain went away in the morning and I was fine. On the third day after the second dose, I woke up with a rash all over my body and again had pain throughout the night only this time I woke up with swollen hands. It?s now been two weeks since my second dose and I am still experiencing hand pain, though improving. My hands feel sore and tight.

Large amount of Bleeding at time of injection. Enough to spill all over the floor and my arm and clothing. Rhen i had a severe rash weeping snd bleeding and red and bruised face and neck. Itching and hard to breathe as well as pain all over Face where rash is scabbing and oozing.

101.8 fever, body aches, cold sweats, chills, pain at injection site, sore arm (arm where injection was), fatigue, headaches, joint pain, whole body in pain to the touch, starting around 9pm day of shot 2/11/2021. Continuing until today 2/12/2021 fever still at 101 unable to go to work

Anaphylaxis. Hives, anterior/posterior throat swelling, shortness of breath. Resolved with epinephrine drip, receiving three epinephrine injections and Benadryl from EMS. Likely will be kept for observation given epi drip.

8/10 pain at the injection cite. Started 12 hours following the vaccine administration and resolved around 24 hours following administration of the vaccine.

3:30 Rash w/ 25mg of Benadryl. Director of nurses observed rash; Observed til 4:30 - reviewed with director of nurses - was fine to go home

Skin sensitivity that feels like a sunburn from elbow to middle of back (covering the shoulder blade on the side where the vaccine was injected). Painful sunburn sensation for the first day or two after presentation, but has lessened to more of an irritation 11 days later. Definitely still present though. No visible rash or marks.

My left arm (site of injection) was burning during the first hour after getting the vaccine (02/11/21). It was sore for the first two days. A bruise formed on day 4 and grew in size. On day 5, a body rash formed on my entire back and began radiating to both arms and neck on day 6 (which is still occurring today, 02/16/21).

Pain at injection site, muscle tightening, increased muscle spasms, hard to move left arm and left leg, burning, tingling, and numbness in left extremities and neck and face and back. Onset progressive peaking five days after vaccine and waxing and waning since.

Arm soreness on day of injection which went away by the next morning. 8 days after initial injection, woke up with redness, pain, and a hard lump that also itches at the injection site.

Tuesday AM got her COVID-19 vaccine number 2 +subjective fever, chills, headache that day of. Temp was 99.4 Tuesday Tired and body aches yesterday (Wednesday) Those all have resolved now Right hand 17 Feb started to feel itchy. Left arm sore. 18 Feb noticed onset of rash on her bilateral ventral forearms (about palm to elbow) that is faintly red, raised, and itchy. No other rash elsewhere at that time She has noted what feels like swollen lymph nodes (lumps) in her left axilla No other reported symptoms; CP, SOB, GI sxs No reactions to the first COVID-19 shot

Complained of congestion and difficulty swallowing post-vaccination. Denied itching/coughing. Reported 1 episode of vomiting. Also complained of feeling light headedness. Reported feeling similar reaction from 1st dose of same vaccine and improved with Benadryl (person did not initially report having taken Benadryl and difficulty swallowing from 1st dose of same vaccine; prior to receiving 2nd vaccination, person had denied to clinic staff of having problems with 1st dose). Person also noted to have rash on left forearm. Vital signs stable. Provider gave person 2 tabs of Benadryl at 12:05pm. Person appears well but was transferred to the Emergency Room for further evaluation due to concern for difficulty swallowing.

Patient had onset of blistering to ears, armpits, back of legs and groin. Patient decided to not get 2nd dose after reaction to 1st dose.

8 days post completion of the COVID-19 Pfizer 2 vaccine series, herpes zoster (shingles) outbreak began on the left forehead with ocular migraine and hypersensitivity of the left medial portion of the face. Valacyclovir 1000mg TID x10 days was initiated within 24 hours of onset, and rash continued to progress down the face to the left eyebrow, left nostril, and left upper lip. Pain and hypersensitivity of the left upper jaw and teeth began on day 3 of zoster outbreak, and ocular migraine increased in intensity. The rash began to blister on day 4, and is continuing to blister and weep currently (day 5).

Climbing Fever starting around 9:00 pm with current temp of 102.2 as of 10:50 pm (body temperature usually <97). Severe chills onset around 9:30 pm. Mild Soreness at injection site starting approximately two hours after vaccination.

Reported generalized pruritus, diffuse rash: face, neck, BUE, torso. Lethargic anxious HR 90, RR 20, Administer Epi injector right thigh. Given IM Benadryl. Transported to ER.

Rash appeared on the trunk, small red maculopapular spots, bright red in color, slightly itchy, with clusters of a few at each spot. Majority of the spots appears within the bra line of the patient, started about a week and a half after the first done (1/22/21) but became increasingly worse two days after the second dose (was received on 2/12/21). First there were many more on the trunk with some patches increasing in size and rash starting to appear on arms and legs as well. Tried benadryl, fexofenadine, and hydrocortisone which helped minorly. Sought medical advice in the clinic (5 days post second dose) and couldn't identify other source of rash (no new product, no bugs bites, etc). Was prescribed triamcinilone acetate cream to help relive itching and redness, which as of 2/24/2021 is improving slowly.

I received the 2nd dose of the Pfizer COVID-19 vaccine around 9:15 am on 2/23/21. Initially, my only symptoms were injection site soreness and minor swelling. Gradually throughout the day, my entire left arm become more and more sore. By 5:00pm, I felt exhausted and dizzy and was having chills. My temperature was 99.8 degrees Fahrenheit. I took a dose of Extra Strength Tylenol, but felt no change. My joints and muscles began to ache around 6:00pm on 2/23/21 and did not stop aching until around 9:00pm on 2/24/21. During the evening of 2/23/21, my dizziness increased and I felt as if I would pass out any time I sat up or stood. My temperature had returned to 98.2 degrees Fahrenheit by 10:00pm on 2/23/21. I then took a dose of Motrin to help with my soreness. On 2/24/21 from morning until 8:30pm, I had no fever or chills, but still felt exhausted and had minor muscle/joint achiness. I took 3 doses of Motrin on 2/24/21 to help with the soreness. Throughout the day, I had some difficulty breathing (felt like a mild asthma attack) and used my emergency inhaler once. At 8:30pm on 2/24/21, my temperature was 100.5 degrees Fahrenheit. I took another dose of Motrin and went to sleep. Around 3:00am on 2/25/21, I woke up drenched in sweat, but feeling better. My temperature was normal then. When I woke up at 7:00am on 2/25/21, I no longer felt achy, dizzy, or tired. I still feel (now at 1:30pm on 2/25/21)as though my asthma is aggravated, but am not having difficulty breathing.

I have an itchy rash all over my body; little white bumps; This is a spontaneous report received from a contactable consumer (patient herself). A 27-year-old female patient (not pregnant at the time of vaccination), received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number; E19269) via an unspecified route of administration on right arm on 03Feb2021 18:30, at single dose for COVID-19 immunisation. Medical history included allergy to sulfa drugs. Concomitant medications included unspecified birth control within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient stated that she had an itchy rash all over her body, they were little white bumps on 04Feb2021. The patient was not received any treatment for the events. The patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. Seriousness of the events was assessed as non-serious by the reporter. The outcome of the events was reported as not recovered.

anaphylactic like reaction immediate flushing, redness, itching, disseminated, irregular breathing, nausea, dizziness,

Dermal Hypersensitivity after 1st dose on1/21/2021. It got better and then I had the 2nd dose on 2/14/2021 and it is back

Severe muscle pain; Itching in the left arm; rash in the left arm; cold sensation, like it was freezing; severe allergic reaction; Bell's Palsy; This is a spontaneous report from a contactable consumer (parent). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL9262), via an unspecified route of administration in the left arm, on 23Jan2021 (at the age of 27-years-old) at a single dose for COVID-19 immunization. Medical history included Bell's Palsy (motor nerves involved) from 2017 to 2017. Concomitant medications included unspecified birth control. The patient had no prior vaccinations within four weeks of vaccination. The patient experienced Bell's Palsy, severe muscle pain, itching in the left arm, rash in the left arm, cold sensation, like it was freezing, and severe allergic reaction on an unspecified date. It was reported that the Bell's Palsy lasted 8 days and was considered a modified Bell's Palsy because it only sensorial nerves were involved. It was reported that the patient did not receive any treatment for Bell's Palsy. The clinical outcome of Bell's Palsy, severe muscle pain, itching in the left arm, rash in the left arm, cold sensation, like it was freezing, and severe allergic reaction was recovered on an unspecified date.

Persistent and painful lymphadenopathy in left armpit that started T+36 hours after vaccination. At 7 days after administration of the vaccine, lymphadenopathy in left armpit persists and remains painful. At 7 days post vaccination a 2 inch patch of swollen skin appeared at the injection site. This is accompanied by redness, itchiness, and pain.

Fatigue - 4 PM - 02/26/2021-Present Nausea - 5 PM - 02/26/2021-Present Headache - 5 PM - 02/26/2021-Present Inject Site Soreness - 5 PM - 02/26/2021 Increase in Abdominal pain - 5 PM - 02/26/2021-present 101.2 Fever - 5 PM - 02/26/2021-02/27/2021. Lowered to 100.1 2/28/2021-present. Muscle aches - 6 PM - 02/26/2021 - lasted through the night only Dizziness - 10 PM - 02/26/2021-present Dry throat and mouth/unquenchable thirst - 10 PM - 02/26/2021-present Loss of voice (no sore throat) - 11 PM - 02/26/2021 Heart racing - 02/27/2021 since waking up - lasted about 30 hours Rash on left shoulder and arms. Itchy. 2/28/2021 - 9 AM to present

Left armpit lymph began to swell to beyond normal measures stretching my Brachial artery and plexus causing loss Of blood flow to my hand and feeling

Sore arm where injected within an hour or so, became more sore over the next day followed by chills, body aches, headache and slight fever starting the morning after vaccination; Sore arm where injected within an hour or so, became more sore over the next day followed by chills, body aches, headache and slight fever starting the morning after vaccination; Sore arm where injected within an hour or so, became more sore over the next day followed by chills, body aches, headache and slight fever starting the morning after vaccination; Sore arm where injected within an hour or so, became more sore over the next day followed by chills, body aches, headache and slight fever starting the morning after vaccination; Sore arm where injected within an hour or so, became more sore over the next day followed by chills, body aches, headache and slight fever starting the morning after vaccination; This is a spontaneous report received from a contactable consumer (patient). A 27-year-old female patient (not pregnant) received first dose of BNT162B2 (COVID 19, Pfizer, Solution for injection, Lot number: EL3247), intramuscular on left arm on 27Jan2021, 10:00 AM at single dose for COVID-19 immunization. Relevant medical history included minor allergies to avocados, almonds, and kiwis. Concomitant medications in two weeks included birth control and Vitamin D NOS (vitamin D supplement). No other vaccine was received by the patient within four weeks. On 27Jan2021 at 11:30 AM, the patient experienced sore arm where injected within an hour or so, became more sore over the next day (28Jan2021) followed by chills, body aches, headache and slight fever starting the morning after vaccination on 28Jan2021. No treatment was received by the patient. The patient was not tested COVID prior and post vaccination. On 03Feb2021, the patient stated that on 27Jan2021, the patient received the vaccination and first had the soreness. The patient reported on 29Jan2021 when patient had recovered from symptoms. The outcome of the events was recovered on 29Jan2021. No follow-up attempts are possible. No further information is expected.

Pt states "I received my second covid vaccine at 3:30pm on 02/25/2021 and I started feeling really tired about 20 minutes later at approx. 3:50pm. I started getting really hot and sweaty. I had my temperature taken and it was fine 97.6. My chest turned really red, and I got really sleepy. By the time I got home at 5:00pm my temperature was at 99.0. I had a headache, muscle aches all over, and chills. That evening my temp was 99.6. I took 500mg Tylenol around the clock. It hurt to move and to get up to go to the bathroom. The body aches have went away but I am still feeling really fatigued today 03/02/2021. I don't feel 100%."

UNKNOWN COVID VACCINE BRAND; chief complaint of generalized body aches and increased heart rate onset today. Per the patient, symptoms are beginning in the context of having received the second dose of her COVID-19 vaccine. Patient reports similar symptoms after her initial dose; however, these resolved shortly after. Patient states that she went to an urgent care for her symptoms but was sent to the ED for further evaluation. Back pain is describes as achy and constant.This initially began at the injection site but began to involve the back. Patient reports taking Tylenol around 1000 today without improvement in symptoms. Administered acetaminophen, magnesium (hypomagnesemia), 1 L NS bolus

My face broke out in hives; My face broke out in hives/were itchy and hot/ itching; My face broke out in hives/were itchy and hot; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247; expiry date: unknown) via an unspecified route of administration in the left arm, on 25Jan2021 at 09:00, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) in the left arm on 04Jan2021 for COVID-19 immunization. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On Friday, 30Jan2021 at 11:00, the patient's face broke out in hives. They were itchy and hot, and it was sudden, over the course of 15 to 30 minutes after the itching, they appeared. The patient took cetirizine hydrochloride before bed and applied cooling balm. The hives were gone this morning. The events were considered non-serious. Outcome of the events was recovered. The patient has not been tested for COVID-19 since vaccination.

Light-headness within forty five minutes - a little dizzy; tiredness; nauseous; swelling on injection site - it was a little worse then on the first dose (I forgot to mention that I had swelling on the injection site after the first dose, too). These symptoms lasted for about two weeks. I took Benadryl to help with the symptoms - it helped the symptoms to let me to sleep. A week and a half before I took the second COVID vaccine, I had a TB test done. Exhaustion is still there and I still have nausea. Dizziness has been gone since second week of the 2nd dose of vaccine. Swelling on the injection site is gone. I had a doctor visit - Video visit with clinic and the dr recommended bedrest - February 11th or 12th - no meds given. I'm due Sept 26, 2021. This is my fourth pregnancy - I had my daughter who is eight years old; an abortion; had my son who is five and he was born pre-term due to lack of fluids in the stomach - 4 lbs 5 oz. and now this pregnancy.

Soreness at injection site throughout day. Experiencing unusual tiredness, sleeping at 7 or 8 PM, but normal sleep time is 12 or 1 AM.

Occasional soreness at injection site. Continued experience of tiredness, sleeping at 7 or 8 PM, when normally sleeping at 12 or 1 AM.

First day: chills, headaches, muscle aches, joint aches, second day: itchy rash on hands, feet, and breasts, itchy eyes and nose, sneezing

Pain in left arm near injection sight; pain when pressed or when arm raised and using the muscles in that area. Slight tickle in back of throat.

Pfizer-BioNTech COVID-19 Vaccine EUA The day after getting Vaccine injection site and entire arm it was administered had following symptoms: Weak, Tender, Muscle Pain, Warm to Touch, and overall achy/sore. The day after my whole body felt weak, lethargic, feverish, sweaty and tired. I ended up sleeping for 14+ hours as well.

Nausea, low grade fevers, lethargy ,Psoriasis Rosasea a few days after but dermatologist didn't think it was from the vaccine

Approximately 90 minutes after vaccination, patient reports noticing 1 hive on left cheek, then within another hour developed hives on face, neck, back, and progressed to chest. Then patient reports tingling and itchiness on lips and in an around her mouth. At this point the patient took benadyl (diphenhydramine) OTC 25mg tablets. Hives resolved post-benadyl within 60 minutes and continued itchiness on skin until next morning. All symptoms/hives/itchiness resolved by next morning.

First, I had moderate pain in my right arm and near the injection site. After the first dose, my right arm and hand became numb with loss of feeling or touch. This lasted for most of the evening, about 12 hours after vaccination. The injection site and the muscle were in a lot of pain, which climbed up into my neck muscle. I did not have any fever or chills. For the past several days, I have become fatigued very easily. Lastly, my lower abdominal area has become sore with discomfort. I have never experienced this before, and I am not currently menstruating either. Tylenol makes it better, and resting on my back and excess movement makes it worse.

I was nauseous after the shot but it may have been hunger and nerves. I had itchy skin for a little bit on my face and arms. Then it went away. I got home around six pm. I had to go to the bathroom and first go was a mix of diarrhea and solid stools. Then as soon as I left the bathroom, I had to go back. It was fully blown diarrhea. Then I kid you not, my period came on at the same time. It is usually unpredictable but I wanted to add it just in case. And my arm became really really sore around 8pm and last night I could barely move it from the pain, or lift it. This morning it is still sore...and hurts to put pressure on .

Red eye lids, itchy, inflammation of eye lids. Soreness of arm and skin rash/slight breakout near point of injection on left arm only.

Patient discharged from vaccine event asymptomatic at 1645, returned to work, then came back to vaccine tent at 1800 stating she had a "splitting headache, was cold, clammy and nauseated." Vital signs SPO2 99% HR 72 and regular, Blood pressure 148/98, skin dry, hands cool, at this time denying nausea, still with complaints of headache. At 1830 HR 75 regular heart rate remains regular, SPOS 99%, denies any airway issues, declined water or crackers, wanted to go home.

Reaction: Red dots on bilateral arms, no itchiness or warmness Outcomes: Observed for an additional 15 minutes, gave Benadryl 25 mg PO x1. Decreased redness after 5 min of Benadryl

I was vaccinated with the first dose of the Pfizer vaccine on 3/3/21. I started experiencing itching on my chest and back on 3/4/21. The itching sensation increased and I broke out in hives on the evening of 3/5/21. I took an antihistamine and the hives subsided. The itching and hives started near the vaccine injection site on my left arm and spread across my chest, back, and to my right arm.

?Dizziness almost immediately and still ongoing ?Tongue tingling about 30 minutes after shot and subsiding around 1:51 ?Pain at injection site ?overall out of it ?off? feeling ?Feeling of panic ?Fatigue ?Chest feeling heavy at about 12pm on day of vaccine lasting about an hour

Pt with hx of anaphylactic reaction to several medications. After 30 minutes, pt feels tingling and itchy skin on entire torso. No hives noted. No other symptoms. Actions Taken: Vitals taken at 1722 as follows: 135/82, HR 86, Respirations 14. O2 sats on RA 95%. No c/o shortness of breath, throat closing, itchy throat, SOB or stridor. After 15 minutes, Pt feels the same and no changes for the worse. Vitals at 1738 as follows 119/68, HR 85. O2 sat 96% on RA. Pt requests to head home and will take Benadryl upon arrival. Disposition: PT d/c to home per pt request @ 1820

Stark dark red rash on lower left breast and abdomen. Started 03/14/21 in the middle of the night when I was sleeping. In the morning it was still there so I took a benadryl with no relief. It became more inflamed, started itching and came with discomfort. Began feeling feverish and dizzy. Saw an NP 03/15/21 around 2:00pm and was given steroid cream to treat what she thought was an allergy. Steroid cream and cold compresses were used over the course of the next two days with no relief. Rash seemed to get bigger and darker. The rash is 4-5 irregular, textured and raised clusters about 1-2 cm in size, with mildly erythematous areas surrounding them. Saw an MD 03/17/21 around 1:30pm, believes it's a vascular response to the vaccine as the color of the rash doesn't fade when pressed on. Advises getting a biopsy if issue does not resolve or improve after 1 week. He also advised holding off on the second dose until further information is obtained

Chronic hives, excessive itching, swelling of lymph nodes, skin rashes, extremely dry skin, constant muscle spasms.

Less than 5 minutes after receiving the vaccine, I experienced tingling in my left fingers. Less than 15 minutes of receiving the Covid-19 Pfizer vaccine, I experienced chest tightness and shortness of breath. I thought I was having an asthma attack, so I proceeded to use my inhaler. After using the inhaler, I started coughing while trying to breathe. Next my tongue started swelling, followed by my throat and back of the tongue. The nurses / EMT reported that my face turned red and my heart-rate was elevated. The EMT proceeded to give me EpiPen, which almost instantly caused the swelling in my tongue to go down. While being monitored for 3 more hours at the emergency room, the swelling went down even more and breathing became more normal. The following day, I visited my allergist doctor, and I was still experiencing some swelling in my neck and chest tightness. I was given a steroid shot, which seemed to clear the rest of the allergic reaction.

Pfizer-BioNTech COVID-19 Vaccine EUA Facial rash over mouth and lips, itchiness, burning, swelling, followed by cold sores

Client came to charge nurse complaining of red rash appearing on arms and chest 15 minutes after vaccine administration. Patient was not in any visible distress. Vitals taken, blood pressure 148/111, HR 103, O2 97%, RR 20. Patient does not complain of any pain or discomfort, trouble breathing or itchiness. Benadryl 25 mg PO administered for red rash on arms and chest. Patient rested, upright in chair for additional 15 minutes. No new complaints brought up by patient. Vitals at 5:09 pm 134/90, 98 pulse, 96% O2, 98.5 temp, RR 18. Lung sounds clear. Patient able to tolerate walking and was accompanied by partner. Patient left site without incident.

I had minor hives on my neck and chest. I felt dizzy, foggy, and very fatigued for the rest of the day after getting this vaccine.

Exhaustion Fatigue Weakness Dizziness Itchiness of injection site, face, arms Runny nose Headache

Patient came to Vaccination Clinic to receive first dose of Pfizer vaccine on 3/18/2021. Patient has a medical history of Ehlers-Danlos Syndrome, Mast Cell Activation Syndrome, POTS (Postural Orthostatic Tachycardic Syndrome). Patient received approval from her doctor and specialists to receive Pfizer vaccine. The patient gave verbal consent to receive the Pfizer vaccine and was vaccinated at 1431. The patient was given an observation time of 30 minutes with EMT. At 1505, the patient reported experiencing tingling in the back of her throat. The patient presented with patchy erythema on chest and neck. The patient was brought into the exam room at 1510 and proceeded to lay down on exam table. At this time, the patient's vitals were taken by RN and found to be within normal limits (BP 115/90, HR 88 BPM, RR 15/min). The patient denied difficulty breathing. She reported feeling minor dizziness and minor itching of neck and arms. The patient's vitals were reassessed as the Lead RN drew up 50 mg/1 mL of IM Benadryl. The patient's vitals at 1518 were: BP 120/85, HR 80 BPM, RR 16/min. The patient remained A&Ox4. The patient was given 50mg of IM Benadryl at 1520 in the left anterolateral region. At 1530, Patient's vitals were: BP 117/80, HR 73 BPM, RR 12/min. At this time, the patient verbalized relief of itching in neck and arms. Upon assessment, the patient's erythema on neck and chest had resolved. At 1537, the patient sat up with her feet dangling below her, her vitals were as follows: BP 132/98, HR 73 BPM, RR 13/min. The patient reported "feeling better" and requested to use the restroom. An RN followed the patient to the restroom. Patient's gait was steady and she denied any dizziness or lightheadedness. Lead nurse educated patient on side effects of Benadryl, including drowsiness. At 1544, the patient requested to drive herself home. She was escorted to her car by lead RN. Patient drove herself home AMA at 1547.

pain at injection site/ left arm; pain when raising arm; This is a spontaneous report from a contactable consumer reporting for herself. A 27-year-old non-pregnant female patient received her first dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: 9266, via an unspecified route of administration, administered in left arm on 25Jan2021 at 08:45 (at the age of 27 years old) as a single dose for COVID-19 immunisation. Medical history included asthma from an unknown date, blood triglycerides increased from an unknown date, and drug allergy to cephalosporins from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Six hours after vaccine administration, the patient experienced pain at injection site/ left arm on 25Jan2021, and pain when raising arm on 25Jan2021. The patient did not receive treatment for the events. The outcome of the events pain at injection site/ left arm, and pain when raising arm was recovered on 26Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.

Patient experienced facial rash with dose 1 that was relieved with Benadryl 50mg PO. Patient experienced spreading body rash with difficulty breathing experienced as persistent cough with dose 2. Symptoms were not relieved with Benadryl 50mg PO and continued to worsen. Patient was administered 0.3mg epinephrine IM (as EpiPen), 911 was alerted, and an ambulance took patient to hospital.

Approx. 8 hours after the vaccine I experienced headache, diarrhea, chills and a low grade fever. Also experienced severe pain at the injection site, that worsened over the evening. All symptoms continued through the evening. Also experienced night sweats. The following morning, headache and mild chills were present, but other symptoms had abated. Had minor brain fog. Those symptoms resolved over the course of the day. All symptoms, except night sweats, have cleared up. Night sweats are ongoing.

Red/irritated skin, rash, hives, and itchy skin along both legs (front and back) - I took one Benadryl pill and put anti-itch cream on both of my legs. The rash/hives were gone by morning.

Fever of 104.1 lasting for 24 hours, Brady aches, chills, swelling the size of a baseball and redness at injection site

03/23/21 -sore arm -body aches -headaches -weakness -fatigue -chills 7:00pm -102.5 fever -rash surrounding injection site -slight swollen armpit -cold sweats -headaches -body aches 03/24/21 -101 fever -body aches -chills -cold sweats

PATIENT DEVELOPED RASH IN BOTH ARMS W/IN 10 MINUTES WHICH SPREAD FURTHER TO HER FACE AND BACK, FEW MINUTES LATER SHE DEVELOPED SHORTNESS OF BREATH AND SENSATION OF HER THROAT CLOSING. SHE WAS GIVEN BENADRYL 50 MG IM AND EPI 0.3 MG IM. THEN PARAMEDICS TRANSFERRED HER TO THE EMERGENCY ROOM.

Patient complained of itching and hives 5 minutes post vaccination. Benadryl 50 mg IM @RD given at 1:32pm. Patient felt dizzy. Laid down with feet up. Patient complained of difficulty swallowing and breathing at 1:47pm. Epipen administered on left outer thigh intramuscularly. 911 called. Transferred to Hospital via ambulance at 2:01pm. Vital signs: 1:25pm BP 110/75 O2 sat 98%, 1:30pm BP 110/80 HR 86bpm; 1:54pm BP 120/95 , HR 137 bpm, O2 sat 98%; 1:57pm HR 124 bpm. Lungs clear to auscultation. Called patient at 6:12pm for follow-up. Patient is still in the hospital for observation. She received treatment and under observation.

Soreness at injection site started 3 hours later. Fever over 100F, aching muscles, nausea, fatigue, headache all started at 7am the next day.

Swollen and red left Arm, itchy left arm, tingling and swelling of lips. Applied ice pack to arm and took 2 benedryl tablets. Initial symptom of itchiness and arm swelling presented approximately 5-10 minutes post injection.

chills, fever, muscle aches (especially in back), pain around injection site, fatigue, pain/strain along armpit (arm of injection site)

Broke out in hives on both hands and left elbow. Scalp is also itchy. Itchiness gradually increased throughout the day until I took a Benadryl at 3pm and it mostly went away about 30 minutes later.

fatigue; headache; chills; muscle aches; lymph node swelling; injection site pain; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249) via unknown route of administration on 25Jan2021 02:00 PM at single dose in right arm for COVID-19 immunization at Nursing Home/Senior Living Facility. Medical history included Anxiety/depression, high cholesterol. Patient was not pregnant at the time of vaccination. No other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Allergies to medications, food, or other products was reported as none. Concomitant medications the patient received within 2 weeks of vaccination included paroxetine hydrochloride (PAXIL), loratadine, melatonin, norethisterone (ERRIN birth control). It was reported as in addition to the side effects of fatigue, headache, chills, and muscle aches, I experienced lymph node swelling lasting over a week as well as injection site pain which is still occurring and all on 26Jan2021. No treatment received for the adverse events. Since the vaccination, the patient had been tested for COVID-19. Patient underwent labs and procedure included PCR (Polymerase chain reaction): Negative (Nasal Swab) on 26Jan2021. The outcome of event injection site pain was not recovered, while for all other events was unknown. No follow-up attempts are possible. No further information is expected.

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Seizure-Medium, Systemic: Weakness-Mild, Additional Details: P/T stated she had not ate since yesterday. She has had these fainting spells in the past especially when she gets her blood drawn. Her bp & respirations were all within normal levels. Was a and O x 4. P/t stated she was feeling faint and dizzy then asked for water. Pharm tech then went to notify RN of the situation. At the moment p/t began to collapse from the chair and fell on her right upper forehead which started to bruise and swell. She then started to seize & 911 was called & emt arrived.

Initially told MD had localized itching at injection site, then stated to Dr. per MD that her lips felt tingly

Patient presented with urticaria to back, abdomen, chest, and face with swelling to bilateral orbital region and lower lip. Patient treated with 25mg IV Benadryl, 20mg IV Pepcid, and 50mg IV solu-cortef at 2315. Patient was monitored for 2 hours following medication administration. Improvement of symptoms was noted after observation and patient was discharged home.

Aches and fatigue starting 14 hours after injection and lasting 6+ hours. Chills starting 15 hours after injection, occurring on and off for approx. 5 hours. Injection site pain starting at time of injection lasting for 24+ hours.

Arm soreness and pain two hours after injection. Fatigue and sleepiness. Arm pain at injection site during first night. This happened during the first and second dose.

High fever, uncontrollable shaking, nausea, dizziness, and headache. Pain and swelling at the injection site.

Left armpit began feeling achy for about two days and then ache went away and now red bumps have popped up on my left bicep - not really bothering me but feel somewhat irritated if bicep is against body

Left arm muscle at injection site has been in pain since the vaccine, over 2 months ago. When the muscle is used it almost feels like the muscle is torn. Pain ranges from mild to severe, depending on what the muscle is being used for. Putting weight on the arm to do something as simple as rolling over in bed can cause severe pain. No treatment. I have not gone to a doctor because I don't know what they would even be able to do because at this point it seems like something that isn't going to go away.

headache; itches at the injection site; felt a little nauseous; This is a spontaneous report from a contactable Other HCP. A 27-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2; Solution for injection; Lot number: EJ1686), ), intramuscularly on Left arm on 20Jan2021 13:30 at single dose for covid-19 immunization. Other medical history includes Eczema, hypoglycemic, anemic. Known allergies includes Rondec. I had a baby. I had been weening from breastfeeding in January. As a result I start my menstrual cycle around the same day as I got my first shot. I sort of had a headache before the shot and definitely had one later that day and the next after the shot. I also felt a little nauseous the next day after receiving the shot. I also started my menstrual cycle again 2 weeks later (around February 8) which would be 2 weeks early. I've been on a birth control pill for 6 months and before having a child, would never had irregular periods. My left arm itches at the injection site for maybe 3 or 4 days. Adverse events was start date on 21Jan2021. And did not received any treatment. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 was unknown; Patient has not tested positive for COVID-19 since having the vaccine. The outcome of the event was "Recovered". Information on the batch number has been requested.

Injection site (arm) is killing her; sore arm; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in arm, on 19Mar2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer COVID-19 vaccine this morning (19Mar2021). On 19Mar2021, the patient's injection site (arm) was killing her (as reported) and she was advised not to take paracetamol (TYLENOL) unless she had severe symptoms and would like to know if she can take something for her sore arm. The outcome of the event was unknown. Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.

About 1 hour after nausea, pain at the site of injection, headache. About 2-3 hours after joint pain, fatigue, and low grade fever + earlier symptoms mentioned above.

8am on 4/4 - extreme chills, muscle and joint aches, fatigue, fever, skin feels sensitive (small normal touches hurt), back area between shoulder blades burns and hurts but no rash By 1pm on 4/4 - now hot, still muscle and joint aches, fatigue, and fever, back burning and skin sensitivity continue - took 2 aleeve By 8pm on 4/4 - felt better, no chills or feeling hot, less joint aches, still muscle aches, back burning and skin sensitivity continue 7am on 4/5 - Felt much better, only slight muscle aches , back burning and skin sensitivity continued - took one aleeve before work 6pm on 4/5 - still feeling better, slight muscle and joint aches. Skin sensativity is much less. Back burning continues. Injection Site: for the first shot, I had no injection site redness or swelling. After the second dose (1:30pm on 4/3), the morning of 4/4 I noticed my arm was extremely swollen, hard, and hot at the injection site. About the size of a fist in terms of the amount of area and raised enough to be visible. Felt much hotter than surrounding skin and extremely red. Hurts to the touch. By 6am on 4/5 red area had grown slightly larger, than night before, still hot, hard/swollen, and painful to the touch. By 6pm on 4/5 red area has grown slightly again larger than this morning, still hot, hard/swollen, and painful to the touch. Waiting another 24 before seeking medical advice.

Patient states that she has tightening , chest tightening and swelling of the tongue. Patient was transported to the ER by ambulance.

The morning after receiving 1st Pfizer COVID vaccine patient awoke with multiple quart-sized bruises on bilateral medial aspects of thighs. No pain, tenderness or swelling reported. She denied personal or family history of bleeding disorder. She denied a precedent trauma. CBC was within normal limits on 4/2/2021. On 4/6/2021, she denied any further bruising and those present were fading. patient reports her sister had similar atraumatic bruising on inner thighs after 1st COVID dose as well.

Allergic response about an hour and a half after the shot was administered. Minor swelling of the lymphnodes, headache, slight itching of my throat and broke out in hives on my neck and chest. Took some ibuprofen and went away.

The patient experienced mild pruritic rash on chest with out compromised breathing about 20 minutes after the vaccine. The rash resolved and the patient left on their own accord.

About 6 hours after the Pfizer COVID vaccine she developed rash and some tongue swelling. Went away with benadryl.

Within 5 minutes of receiving the Pfizer COVID-19 vaccine, I had terrible hot flashes and was unable to focus. This subsided within 15 minutes. Within an hour of the vaccine, my tongue went numb and mildly swelled, my face grew hot, and my throat swelled. It was difficult to swallow saliva and water. Within two hours, I grew progressively weaker, light-headed/dizzy, and experienced mild confusion (unable to understand what folks were saying on the onset). I also had quite low blood pressure when observed by the EMTs. My swelling subsided within 5 hours, both through time and the eventually emergency room treatment of Benadryl, Prednisone, and saline.

Injection site pain in left arm (started at 7pm 4/1/21, ended 4/3/21 around 12pm) Redness around injection and across left shoulder, injection site/left shoulder felt very hot (started around AM of 4/2/21 - exact time uncertain). Slight chills (started around 3AM 4/02/21, ended shortly after) *Skin sensitivity - My upper torso (arms, chest, back, shoulder, neck, and abdomen) felt hyper-sensitive to all touch (not painful, but significantly uncomfortable). This started around 11AM 4/02/21 and ended around 9AM 4/03/21. Slight shortness of breath - not significant or burdensome. (Started 4/01/21 around 9PM, ended around 10PM 4/02/21). No other symptoms to 2nd dose of Pfizer. All symptoms were gone by 4/03/21. Took 1 Tylenol tablet around 11AM 4/02/2021 for injection site/left arm pain.

Patient received Pfizer Vaccine (Lot # EP7534 Exp: 3/20/2021) @ 12:48 PM on left deltoid. Prior to vaccination, patient stated to RN vaccinator, I feel anxious with needles. RN approached patient calmly and explained risks/benefits of vaccine. RN received verbal consent to give vaccine to patient. At 1300, patient at EMT station complaining of lightheadness, tingling in the mouth, and stated feeling anxious. Past medical history includes auto immune disease. No history of severe allergic reactions. Patient reported that she ate 3 hours ago. EMT noticed flushing of the face. At 1305, patient laid down in recliner chair and water offered. Vital signs taken every 5 mins. Patient alert and oriented x3. At 1310, BP 137/95, P 96 strong, RR 16 unlabored. At 1323: BP 138/100, HR 92 thready, RR 12. Upon assessment, skin warm to touch and normal skin color, damp palm, shaky arms and legs. Patient says "it feels like previous panic attack", and reports tingling in the mouth improved. At 1325, RN offered EMS to patient but patient declined. Vitals at 1330: BP 130/90, P 84 thready, RR 14. At 1335: BP 130/90 P 86 strong RR 14. At 1342: BP 120/80, P 80, RR 12. At 1337, 100 ml juice given and patient contacted her boyfriend to pick her up. At 1357, patient left the facility without assistance and with a steady gait.

At time of vaccine (04/07 11:45 AM) was light-headed and had shoulder pain at injection site but no other adverse effects during observation period. While driving home, had some tingling/numbness in left arm and knees with persistent pain in shoulder. Felt fine other than shoulder pain and slight headache until that night. I went running after finishing work (around 7 pm) and started experiencing intense tingling/numbness all down left arm to hand as well as intense knee pain not typical during running, at which point I stopped running and went home. When I got home I noticed my left index finger had lost circulation (was white). That night I experienced moderate but increasing fatigue as well as chest pain and tightness. My hands both felt numb like they fell asleep/lost circulation, as well as my left arm and feet. The next morning I felt better but the fatigue and numbness in my hands and feet started up again around 10 am and lasted for several hours. I had some chest pain that night (around 11 pm) and a headache on and off throughout the day. Today (04/09) I felt completely fine. I did start my period the day before my vaccine (04/06) and was having heavy bleeding/cramps that day and a bit throughout the time described above.

Initially started as slight arm soreness in the hours immediately after the vaccine. Woke up in the middle of the night Thursday morning with nausea and dry heaving along with severe joint pain in the ankles, knees, shoulder, lower back, and wrist, chills, and shivering. Had a low grade fever the entire day Thursday and into Friday despite taking acetaminophen. Joint pain was barely relieved by Tylenol. Arm and joint pain still persistent. Slight sore throat also present. Also pain sensation seemed to be heightened. Putting lotion on was painful, others touching my skin was painful, etc. The highest severity of symptoms was on Thursday but are persisting into today.

Sore muscles (24 hours after injection), headache (1 days after injection), malaise(1 days after injection), hives/body rash (occurred 6-7 days after injection and has lasted 7 days from onset)

Within five minutes: racing heart beat, full body flush, tingling and burning mouth and tongue, itching on chest and arms.

Body aches, fatigue, brain fog, severe rash on face especially around eyes and cheeks. Lasted more than a week and only got better with topical steroids

Itchy in the area were the vaccine was given, but in that arm I had the tuberculosis vaccine as well. It turned red on that area.

Patient stated that starting the day after vaccination, she developed an itchy rash on chest and arms. She was told to take Benadryl 25mg every 4 to 6 hours in the evening and use 2% cream during the day until she can seek medical treatment

Swelling and rash development at the injection site. Site was hot and stiff. Medics treated with anti-histamine and ice.

Noticed rash on both arms a few inches from armpit same day as vaccine. Next day, I noticed more rashes. Rashes have kept coming up all over body. Aside from fever, chills, fatigue, and migraine on Monday night, I haven?t had any other symptoms (besides rash). Doctor said it looks like I have Erythema Multiforme.

Minor anaphylaxis and hives/heat rash behind underarms near shoulder blades. Sensitivity to sunlight. Minor anaphylaxis-started about 2 hours after injection and lasted approximately 8 hours. Resolved fully by next morning. Hives/heat rash behind underarms near shoulder blades-started about 3 hours after injection. Was made worse during sunlight exposure. Are minorly itchy. Sunlight Sensitivity lasted for about 24-48 hours. Seems to have resolved.

Numbess, weakness, and "pins and needles" sensation that started in my left arm (injected arm) on 4/14/2021 and has not traveled to right arm, and both legs.

Complaint of tongue swelling, itchy, and dry mouth, Pt alert & oriented x 4, 4:40 PO Benadryl 25mg, Pt's symptoms resolved and left to go home.

Hives from head to toe and tightness of throat. Provider gave me a Decadron (steroid shot) and high dose oral prednisone. Even with shot and oral steroids it took 5 days for the hives to go away and another 4 days for my throat to feel normal again.

One day after the vaccine, a lump formed on the left side of my groin, along bikini line, which seemed like a swollen lymph node. Originally it was pea-sized, then the next day tripled in size and became red, hot, and very tender. Over the next week it reduced in size until it healed. Over the two days after the vaccine, I was very tired and my arm where I received the vaccine was very sore and bruised. The bruise and soreness lasted about 1.5 weeks.

fever, rash, hives, palpitations, headache, syncope. Lasting 7 days after vaccination. Evaluated in the ED on 7th day post vaccine.

Shortly after vaccination, 10 minutes, Patient complained of itching, hives were observed on arms, face was red. Pt stated chest felt heavy. epi pen adminstered .3mg, 50 mg of benadryl given, Patient was evaluated by EMS, vitals stable , hives did not worsen. Patient was transported by EMS to Emergency Room for further assessment.

10/10/21 , pregnant with second child and currently 200 lbs I had a reaction of severe itching and hives

Rash/ hives developed around my neck over a week after vaccination. My sister also developed a rash around the neck after vaccination.

After shot felt increasingly nauseous and dizzy and tired. I went to the bathroom and threw up. Upon return to the observation area, I lost consciousness, fainted, and woke up on the floor. My blood pressure was low but within normal range and my blood sugar was normal. I was not nervous about receiving the shot or possible symptoms and do not have a history of fainting not relating to medication side effects (meds I am no longer on) and over exertion ( ie. likely not psychosomatic). Fainting on a hard surface led to a serious concussion with effects (brain fog, fatuige, headache, and dizziness primarily) continue to persist. I saw doctors at an urgent care and them the ER where they performed a pregnancy test (negative), blood sugar test (normal). EKG (normal), and a concussion screening that led to a CT scan (normal). I left with no explanation as to why I felt sick and fainted after the vaccine and was only told later by my psychiatrist to report. The only clear side effect was pain in the arm of the injection site. Other possible vaccine symptoms overlap with concussion symptoms.

About 48 hours after first vaccine dose I started feeling really itchy. Followed by large patches of hives showing up all over my body. Individual patches last about 10 minutes but the hives are continuous throughout the day. Also possibly related, experienced stabbing chest pain a couple times throughout the week. Over 5 days after onset of hives, the severity and consistency has not decreased at all.

15hrs after injection. Developed a rash/hives. Started under arms, spread to breasts, chest, neck, and chin. Then down armpits and eventually top on thighs. Extremely tender and itchy. Treated with calamine lotion and Benadryl.

Right when I received the shot I had a shooting pain from my elbow to my thumb, pointer, and middle finger. I experienced some pain at injection site for about 24hrs, but the pain through my fingers has not gone away and continues to interfere with work. I went to the ER on Wednesday, 4/14/21. The pain was giving me an intense headache and shooting down my back and legs on the right side. They prescribed muscle relaxers, anti-inflammatory, and pain meds to ease the pain. Even with the meds, I still experience high levels of pain when I use my right arm/hand. I am trying to work the best I can, but scrolling, clicking, and typing aggravate the pain.

The moment I received the vaccine I felt pain shoot down to my thumb, pointer, and middle finger. I had the general pain near the injection site, but that went away after 24hrs. I am still feeling shooting pains through the right side of my body, mainly from my elbow to my fingers. It has made me unable to work a full day since scrolling, typing, and clicking all aggravate this pain. If I am using my right arm/fingers too often it turns into a debilitating headache.

Pain in temple, temple is sensitive to touch. There's a pain in my temple when I talk, bite, or hold my jaw. I've never experienced this in my life before. I'm also hearing a constant ringing in my ears.

4 days after vaccine, a migraine headache and fatigue came on. In the night at 3 am , fever was 100.1 and stayed there about between 99.0 and 100.5 from then until present (7 days after shot). Swollen lymph nodes in armpit and groin. Body aches , terribly painful raised rash all over body but especially at armpits. All symptoms continue now at 1 week since shot.

Patient called pharmacy statin that she had purple discoloration and swelling between her middle and ring finger on her left hand. Vaccination was given in the left arm.

Woke up with fever that lasted 36 hours, body chills, body aches that lasted 48 hours. Nausea and vomiting happened 72 hours after injection. Have had migraines starting 72 hours after injection. Left arm was and still is red/hot to the touch and feels like a knot. The day after I couldn't lay on my left arm and it stung/throbbed with pain. Has gotten a little better but it is still very sore and hot to the touch.

4/20/21: Vaccination @ 1:40pm. Vaccination site sore only when pressed. 4/21/21: Upper left arm sore when moved. Upper throat swollen. Began to feel feverish & lethargic c. 9am. Feverish feeling passed c. 11am. Slept 2-6pm. Slept 11:30pm 4/21/21-4/22/21. 4/22/21: Woke up at 1:20pm. Unresponsive to regular alarms. Vaccination site sore only when pressed. Upper throat still swollen, but less-so.

40 hours after receiving the 2nd dose of the Pfizer COVID-19 vaccine, the patient discovered small hives on the underside of arms and thighs. In addition, there is a rash consisting of small red spots that span the underside of the arms, thighs, stomach, back, chest, and neck. The rash is itchy but not hot to touch. Antihistamines both oral and topical have not helped the rash subside.

I developed very itchy bumps all over my body a few days after both the first and the second shot. The bumps were much worse after the second shot and continued to linger for over a month (bumps would fade and new ones would develop. Finally I took benedryl three nights in a row and that seemed to knock them back. I've done everything I can to rule out some sort of bug. The person with whom I share a bed has not been developing these bumps. They do not resemble bed bug bites. The closest resemblance is to mosquito bites, but there are no mosquitos in this area this time of year.

100.2 degree fever, body aches, chills, fatigue; lasted 24 hours Pain in injected arm for three days; difficult to raise or move arm

March 26 2021= 1st does of Pfizer vacc site pain and heaviness of limbs April 1 2021= woke up at 3 am with chest discomfort MD visit=high blood pressure(BP) and EKG (normal), prescribed HCTZ 25 mg daily ER visit=chest discomfort/dizziness/heaviness in arms blood work=low sodium. EKG=normal, high BP April 4 2021 ER visit=insomnia/dizziness/globilized weakness/muscle spasm Given IV and pain meds, no labs or test were done stopped taking HCTZ April 5 2021= ER visit=Facial drop (right side), weakness,back spasm, feeling of ants on face/chest and arms blood work to check sodium=normal, bp=normal, given blood pressure meds and sent home (not very good doctors) April 6 2021= Taking HCTZ due to swelling facial drop April 6 2021= Taking HCTZ due to swelling facial drop was gone (face back to normal) started taking baby aspirin ASA due to recommendation of aunt (who is a doctor) CT HEAD=normal April 7 2021=Taking hctz and ASA daily started monitoring BP at home dizziness and head aches took exedrin bp normal all day April 8-13 2021 Chest discomfort and pain (would move sides depending of the day) insomnia (1 night) tension headaches muscle spasm on and off feeling of ants on arms no MD visit or ER visit during this time BP normal during this time during this time i did not believe that my symptoms were due to the vaccine/ i thought it was lasting effects of covid (covid long hauler) April 14 2021=2nd dose vaccine pfizer April 14-19 symptoms persisted but intensity and frequency subsided the chest discomfort was duller no more feeling of ants minor swelling of the throat (could still breath,drink and talk) cut HCTZ dosage in half bp normal April 20 2021 Chest discomfort in the night (like on april 1) discomfort would not let me sleep bp normal all day April 21 2021 muscle spasm on neck and back burning sensation in left side chest going to the left arm April 22 2021 MD visit (did not believe me when i told him it may be side effects of vaccine) refferal for blood test (no results yet) April 23 2021 stopped taking diuretic hot face(no fever 37.6 C) swelling of face (these symptoms started around 7 am) Took Benadryll bp normal ER visit (different hospital than other visits) tingling on left arm and face (right side) (around 1 pm) facial drop (right side) bp high EKG=normal/CT scan=normal/chest x ray=normal/covid, influenza and microplasma=negative/ blood work =normal (electrolytes ok)/troponin=.017/urinalysis=normal given benadryll and saline solution IV told that these are symptoms of the vaccine and to ride it out with aspirin and benadryll April 24 2021 (today) hot face, swelling of hands (for now its early in the day) no bp readings yet Seeing that the symptoms were restarting at around the same timeframe as the first dose I now think that these may be secondary effects of the vaccine

Itchy on face head neck and ears. Red blotchy rash on face and neck Took two benadryl and lots of water rash and itchiness lasted until 9pm of 4/16/2021

Fever (starting 12 hours later and lasting 8 hours) body aches (starting 12 hours later and lasting 24 hours), headache (starting ~8 hours later and lasting ~30 hours), pain at injection site (starting ~3 hours later, lasting 48 hours)

First shot: evaluated heart rate, BP increased within 3 minutes of receiving the first vaccine. Throat itchy/ closing 1 hour after first shot. Treatment Benadryl and ibuprofen. Small rash on chest and lower left and right leg and buttocks 2nd shot: Rash/ hives on left and right arms and left and right legs, stomach and chest. Treatment outcome: steroid injection from urgent care. No change. Prednisone 10mg for 6 days. (21 tablets) Prescribed by my primary doctor Dr. No change therefore I contacted my dermatologist and she prescribed Triamcinolone acetonide ointment for 2 weeks twice a day for the itching and inflammation. No change.

Developed a rash under left breast, slowly spread around the ribs to my back. Was diagnosed on Monday april 12th with shingles

Fever 99.1 F morning after vaccination, fatigue and malaise the first day, myalgia and arthalguia the first day, injection site site for two days following vaccination, redness and swelling at injection site beginning on the second day after dose, diarrhea the second day after dose

Dose 1: sore arm at injection site for 36hrs, some fatigue that lasted less than 24hrs Dose 2: sore arm at injection site for 36hrs, full body stiffness and soreness 12hrs after injection followed by fever, fatigue, and headache. Lasting 72 hrs and required 1 day off of work.

soreness of the injection arm; This is a spontaneous report from a non-contactable reporter. A 27-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Solution for injection), dose 1 in the left arm on 14Feb2021 (Batch/Lot number EN6201) as a SINGE DOSE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications was not reported. The patient did not do a test Covid post vaccination. The patient did not receive any treatment. Patient did not receive any other vaccine in four weeks. On 14Feb2021 after the first dose of the vaccine, the patient experienced soreness of the injection arm. Outcome of the event was recovered. No follow-up attempts are needed. No further information is expected.

Left arm pain starting day of vaccine, continued for 5 days after vaccine Low-grade fever for 2-3 days after vaccine Joint pain for 3-4 days after vaccine Petechiae on the back of right hand and distal forearm appeared one week after receiving vaccine

Pt is a 27 yr/o female who presents with general symptoms Had Covid vaccine yesterday Today describes multiple symptoms including headache, fatigue, low energy, chest pressure, shortness of breath, swelling, rash, flushed feeling, etc. No history of true syncope or palpitations No definite fever, chills No history of blood clot or bleeding disorder No current cough or bloody cough

Hard lump at the injection site, it is red and warm, and it is itchy, it also feels like something is still in my arm.

Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Looked like hives; patch about 4x4\", pt given rx for epinephrine, and she took benadryl. Pt did not respond to call back next morning.

My scalp was itchy and I found 2 bald patches on my scalp which was later diagnosed as Alopecia Areata by my dermatologist, the following week. The patches got larger and I am still losing hair after cortisol injections as a treatment 2 weeks ago.

This is a spontaneous report from a contactable consumer (patient herself). A 27-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EN6208, Expiry Date: unknown) on 21Mar2021 10:00 and second dose on 10Apr2021 both via unspecified route of administration in the left arm at single dose for COVID-19 immunization. The patient denied any medical history. She had no allergies. The patient's concomitant medication included celecoxib. On an unknown date in 2021, after receiving the vaccine, the patient had tingling in hands and feet, headache and pins and needle sensation all over the body, and rash and swelling in eyelids. No emergency room or physician office was involved. No COVID-19 prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. There were no relevant test. The patient did not received treatment. The outcome of the events was not recovered. No follow-up attempts are needed. No further information is expected

Tops of toes turning white then blue, cold and now also involves most of the foot. It started approximately 1 week after first dose. It appeared to be worse after the second dose.

The next day after injection, small red circle appeared where injection was given. It was red, swollen, and warm to touch. Sore arm was noted as well. Red mark continued to get bigger for 4+ days until it eventually went away.

fatigue, low grade fever, chills, aches, covid arm rash, nausea, headache, stomachache. treated with otc nasal spray and tylenol.

Hives covering body. Started on forehead and has spread and is still spreading 4 days after. I got steroids starting yesterday and was called and told that I am no longer vaccinated since I took steroids.

At around the 30 hour mark I noticed that my left eyelid had become quite droopy. It appeared to be about half way closed. I didn't seem to have any other symptoms visible on my face but I did end up with random bruising on my right thigh, severe dizziness with nausea, fatigue that lasted about 48 hours and a headache. The fatigue started about two hours after the injection and the rest of the symptoms were the following day.

Rash two days post injection. Starting on neck then spread to arms and legs. Blotchy, non raised, reddened rash that itched and burned when scratched. Benadryl and cortisone cream used with little help. Oral antihistamine such as Benadryl was effective. Rash would go away and return after 1 or a few hours and show in a different area than previously. In the morning and in the evening worse. Rash would show on eye lids and face as well. Lasted about 2 weeks then resolved on its own. Now skin is more photosensitive and blotchy rash will develop with certain creams or sun exposure without specific sunscreen reapplication

Hives; This is a spontaneous report from a contactable Other Health Professional (patient). A 27-Year-old female patient received second dose of BNT162B2 (COMIRNATY, Solution for injection, Lot number EL3247) via unspecified route of administration at arm left on 27Jan2021 at 09:00 AM as single dose for COVID-19 immunization. Medical history included allergies to sulfa antibiotics. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication was not reported. Previously patient received first dose of BNT162B2 for COVID-19 immunization. On an unknown date, patient experienced hives. No COVID prior vaccination. Patient has not tested COVID-19 post vaccination. The outcome of event was unknown. Follow-up attempts are completed. No further information is expected.

3 Hives on neck and 6 hives on right arm.; This is a spontaneous report from a contactable consumer. A 27-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247), via an unspecified route of administration on 12Feb2021 (at the age of 27-year-old), as a single dose in left arm for COVID-19 immunisation at workplace clinic. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient did not receive any other medications within two weeks of vaccination. Patient was not pregnant at the time of vaccination. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247) via an unspecified route of administration on 21Jan2021 (at the age of 27-year-old), as a single dose for COVID-19 immunisation. On 13Feb2021 at 12:00, the patient experienced 3 hives on neck and 6 hives on right arm. There was no treatment received for the event. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the event was recovering. Follow-up (23Feb2021): This follow-up is being submitted to notify that the adverse event occurred date and PRD was 13Feb2021. Information on the lot/batch number has been requested.

Within 15 minutes: dry throat and warming feeling over my face/flushing I drank water and had a snack around the 20-25 minute and put on the AC on high in my car in case it was just anxiety. When I took off my mask around then my cheeks were red and a little bit below my chin was red. After I drank water my throat had that lump in your throat type of feeling. I went to my aunt?s house a hour after the vaccine was given and she confirmed my face and neck were unusually red. I was very thirsty and drank a whole water bottle within a hour and a half of the shot. 2 hours after the vaccine I took half a Benadryl and my face started becoming less red and the warmth feeling started going away. My throat was still dry and lump in the throat feeling for the rest of the night. Ricola cough drops helped soothe it a bit though. I took the other half of the Benadryl 4 hours after the last Benadryl and then went to sleep. Today, my throat is still not great but my face redness has gone away. My arm is sore and hurts more the higher I raise it. Going to email my doctor at lunch and try to find an allergist to connect with about whether I can receive the second dose or not.

Severe arm pain. Throbbing. Muscle spasms at injection site. Numbness and tingling in fingers on affected side. No treatment appears to improve conditions.

AFTER 5 MINUTES OF RECEIVING 2ND DOSE OF PFIZER COVID 19 VACCINE. THE PATIENT COMPLAINED OF PALPITATIONS AND WAS JITTERY. SHE DEVELOPED RASH ON CHEST. 911 WAS CALLED AND EMS CAME AND TOOK PATIENT AWAY FOR OBSERVATION

Patient immediately experienced pain at the site of injection, after her second dose of Pfizer COVID-19 vaccine, given 21-days after first dose. Site of injection was very high, close to shoulder. Arm was initially bruised. Arm on 5-5-21 (at doctor office visit) is not as weak as it was the first couple of day. Still sore to lift her arm. Ache in quality. Patient diagnosed with bursitis from inappropriate injection technique, given too high on arm. Patient prescribed etodolac 400 mg twice day for pain and inflammation.

Left upper arm , at the injection site, hard, warm to touch , erythematous, swollen, tender and measures 6cm X 9 cm. The reaction started after 24 hours of vaccine and called the Nurse line and they recommend urgent care / PCP visit for possible infection. Recommend hydrocortisone OTC to apply for the local reaction at the vaccine site and started on Cephalexin for possible cellulitis related vaccine administration. Recommend follow up with the clinic if the symptoms get worse with fever, chills, n/v.

I had a fever of 101 F about 14 hrs after the 2nd dose of Covid-19 Pfizer vaccine. My entire left arm is painful and felt very tired. These side effects continue about one day and all disappear.

got shingles; This is a spontaneous report from a Pfizer sponsored program received from a contactable consumer (patient). A 27-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that she received the second dose last Tuesday (Feb2021) and she got shingles yesterday (Feb2021). The outcome of the event was unknown. Information about lot/ batch number has been requested

slight fever; chills; Injection site soreness; This is a spontaneous report from a contactable consumer (patient). A 27-Year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3247), via an unspecified route of administration in left arm on 24Feb2021at 03:30 PM as single dose for COVID-19 immunization. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3247), via an unspecified route of administration in left arm on 03Feb2021 at 03:30 PM as single dose for COVID-19 immunization. Medical history was not reported. Patient had no known allergies. Concomitant medications included vitamin d NOS, desogestrel, ethinylestradiol (APRI) as birth Control. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Patient was not pregnant at the time of vaccination. On 24Feb2021 at 09:00 PM (after second vaccine dose) patient experienced slight fever and chills about 5 hours after vaccination. The next day, fever and chills continued. Injection site soreness started a few hours after vaccination and has become quite. No treatment was received. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

Sore arm at injection site; This is a spontaneous report from contactable consumer (patient). A 27-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: 3247), via an unspecified route of administration on 02Mar2021 at 13:15 as 2nd dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient had no allergies. Patient was not pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was workplace clinic. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was queried you have reported about an adverse regarding covid-19 vaccine, please help the first awareness date of this report. You filled PRD as 03Mar2021, however the adverse event start date 02Mar2021, it seemed that you know these on 02Mar2021, could you please help confirm the correct first awareness date for the events. In response, yes, I received my shot on 02Mar2021 at 08:00 PM when I began experiencing the sore arm at injection site (the day I received my vaccine) and reported it on 03Mar2021. No treatment was received for the adverse event. The outcome of the event was recovering. No follow-up attempts are needed. No further information is expected.

A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced a rash within 3 days of receiving the first shot of Pfizer Biontech COVID vaccine. Reporter said the physician thought it might be a resurface of shingles. Rash cleared subsequently without any further complications. The outcome of the event rash was recovered while unknown for the event shingles. No follow-up attempts are possible; information about lot/batch number cannot been obtained

PATIENT GOT A SUNBURN ON SUNDAY PRIOR TO WEDNESDAY OF EVENT; HER RIGHT LEG GOT EXTREMELY SWOLLEN; WENT TO URGENT CARE AND WAS SENT TO EMERGENCY ROOM TO CHECK FOR BLOOD CLOT SKIN COLOR WAS PUPLE/RED - NO RASH; BLOOD CLOT NOT FOUND - CAUSE OF SWELLING NOT FOUND SWELLING RESOLVED ITSELF ABOUT 5 DAYS; FRIEND OF PATIENT GOT SWOLLEN FOOT AND SAME RED/PURPLE SKIN TONE AFTER SECOND VACCINE AND SUNBURN - SAME TREATMENT COURSE - WE HAVE PHOTOS OF BOTH EVENTS.

she gave it down towards her knee on her leg; injection was very painful/some burning during the injection; injected the area swelled up as she gave it and became red; injected the area swelled up as she gave it and became red; had a flare for the past couple of days/pretty bad flare/ put her into a flare/ Feeling really bad; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer from Amgen , license party for etanercept (ENBREL). This non-serious solicited report was reported to Amgen on 05Apr2021 by a consumer from a commercial program and involves a 27 year old female patient who gave it down towards her knee on her leg (PT: product administered at inappropriate site), injection was very painful (PT: injection site pain), injected the area swelled up as she gave it and became red (PT: injection site swelling and PT: injection site erythema) while receiving Enbrel with Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. No concomitant medications were provided. No co-suspect medications were reported. The patient began Enbrel with Single Dose Prefilled Autoinjector on 04Apr2021. On 04Apr2021 last night, the patient took her first injection of Enbrel last night and when she injected the area swelled up as she gave it and became red. The patient reported injection was very painful and she recounted that she gave it down towards her knee on her leg. On 05Apr2021 same day of this report, the patient reported it was sore but no longer red. The patient was referred to HCP and arranged for an in home patient training for next injection. No treatment information was received. The outcome of the event injection site pain was reported as not recovered/not resolved. The outcome of the event injection site erythema was reported as recovered/resolved. The outcome of the events product administered at inappropriate site, injection site swelling were reported as unknown. The event injection site erythema was resolved on 05Apr2021. Action taken with Enbrel and Single Dose Prefilled Autoinjector was reported as unknown for the events injection site pain, injection site swelling and injection site erythema. The causal relationship between the events injection site pain, injection site swelling, injection site erythema, product administered at inappropriate site and Enbrel, Single Dose Prefilled Autoinjector was not provided by the consumer. The reporter declined consent for follow up. No follow-up attempts are possible. No further information is expected. Causality Assessment for the events Pain during injection, Injection site redness, Injection site swelling, per Company (Amgen): related. Causality Assessment for the event Product administered at inappropriate site, per Company (Amgen): Not related. The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Follow-up (12Apr2021): This is a follow-up solicited report from a non-Pfizer sponsored program (marketing program name not available) received from a contactable consumer, based on information received by Pfizer from Amgen, license party for etanercept (ENBREL). ADDITIONAL INFORMATION RECEIVED ON 12/APR/2021 AND 20/APR/2021: This case was upgraded to serious case. In this follow up, it was reported that the patient had a flare for the past couple of days/pretty bad flare [PT: rheumatoid arthritis], some burning during the injection [PT: injection site pain] while receiving Enbrel, Single Dose Prefilled Autoinjector. It was previously reported that the patient first injected close to her knee and had a bad injection experience with immediate pain and swelling at the site. On unknown date in APR/2021, the patient stated that for the past couple of days she had a flare especially in her hands. On 12/APR/2021, the patient stated that she did her injection higher on the thigh to ensure a subcutaneous injection and she had no swelling or pain. On 16/APR/2021 (Friday of last week), the patient had a pretty bad flare that subsided on the weekend prior to her last injection. On 19/APR/2021, the patient injected in her thigh and she had some burning during the injection that lasted for about a minute afterwards. The outcome of the events rheumatoid arthritis and injection site pain were reported as recovered/resolved. The event injection site pain was resolved on 19/APR/2021. The event rheumatoid arthritis was resolved on an unknown date in APR/2021. Action taken with Enbrel and Single Dose Prefilled Autoinjector was continued for the event rheumatoid arthritis. The causal relationship between the event rheumatoid arthritis, Enbrel and Single Dose Prefilled Autoinjector was not provided by the consumer. The reporter declined consent for follow up. No follow-up attempts are possible. No further information is expected. The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Amgen Comment: This individual report does not change the safety profile of the product. Amgen Causality Assessment: Rheumatoid arthritis flare up, Product administered at inappropriate site assesses as unrelated while Injection site redness, Injection site swelling, Pain during injection assessed as related to etanercept. Follow-up (26Apr2021): The following clarification was received from Amgen to clarify the route of administration of Enbrel, included: The event reported was Product administered at inappropriate site "gave it down towards her knee on her leg [PT: product administered at inappropriate site" & "when she injected the area swelled up as she gave it and became red." Following the initial dose that was administered inappropriately, "On 12/APR/2021, the patient stated that she did her injection higher on the thigh to ensure a subcutaneous injection and she had no swelling or pain" The reporter declined consent for follow up. No follow-up attempts are possible. No further information is expected. Follow-up (27Apr2021): This is a follow-up solicited report from a non-Pfizer sponsored program (marketing program name not available) received from a contactable consumer, based on information received by Pfizer from Amgen, license party for etanercept (ENBREL). ADDITIONAL INFORMATION RECEIVED ON 27/APR/2021: The outcome of the previously reported event rheumatoid arthritis was updated to recovering/resolving. Action taken with Enbrel, Single Dose Prefilled Autoinjector for the previously reported event rheumatoid arthritis was updated to not applicable. In this follow up it was reported that the patient experienced a flare/ feeling really bad [PT: rheumatoid arthritis] while receiving Enbrel, Single Dose Prefilled Autoinjector. The patient's co-suspect medication included COVID-19 (corona virus disease-2019) vaccine. On 25/APR/2021, Sunday, the patient received her second dose of COVID (corona virus disease) vaccine. So, the patient skipped a dose of Enbrel therapy. Then on 26/APR/2021, yesterday of this report, the patient felt really bad. She thought the vaccine put her into a flare. She was doing a little better today. She would restart Enbrel later today and switched her injection day to Tuesday. She also mentioned that this time, she didn't have a flare at the end of the week, as she had with her prior dose. So, she thought that without the COVID vaccine, she would had been fine. The outcome of the event rheumatoid arthritis was reported as recovering/resolving. No follow-up attempts are possible. No further information is expected. Amgen comment: This individual report does not change the safety profile of the product. The reporter's assessment of the causal relationship of the events with the suspect products etanercept and BNT162B2 (reported as "COVID vaccine") was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Amgen's Causality Assessment: The events Pain during injection, Injection site redness, Injection site swelling were related to etanercept. The events Rheumatoid arthritis flare up, Product administered at inappropriate site were unrelated to etanercept.; Sender's Comments: The reported events of injection site pain, injection site swelling and injection site erythema were assessed as possibly related to etanercept based on temporal association and known drug safety profile. Reported event rheumatoid arthritis flare is an intercurrent medical conditions and is unlikely related to Enbrel. Pfizer comment: Confirmed the Amgen assessment for Enbrel. The reported events were assessed as not related to BNT162B2. The events preceded, most of them already recovered, at the time of vaccine injection.

the day after the 2nd shot side effect of body aches for 24 hours. Around 2 weeks after the 2nd dose, I noticed vesicular skin rash with pruritus on my arm and stomach. There was no itching and the rash had persisted for a few days.

Face broke out into a rash that was so painful, I could not move my face without it feeling like glass was in my face. Currently I am still experiencing great pain with my arthritis I feel stiffer than the tinman without oil. I also have been having dull pain every now and again in my right side that started once I got my shot.

Hives, urticaria on face and upper body, easier bruising. Gave antihistamine, prednisone, steroid cream, and got labs. Close follow up.

Immediately following injection I, patient became warm and flushed. The next day an injection site reaction occurred. My arm was swollen, red, and warm for 3-5 days.

Severe thrombocytopenia, petechial rash, dehydration, tachycardia, Idiopathic thrombocytopenic purpura. Treatment involved immunoglobulin and steroids. Started immunoglobulin and steroids on April 13, 2021 Platelets started to rise next day. Hospital admit and discharge 4/13/2021-4/15/2021 Taking prednisone at home.

Developed a full-body rash in the hour after vaccine was administered. Rash started as many small raised hives, within a couple of hours my entire body had a raised red rash - the small spots combined to create a full-body rash.Rash was itchy and burning - it took over a week to go away. I could not expose my skin to the sun during this week as it felt extremely sensitive.

April 23: rash occurred on both legs with significant amount on left leg . Rash was very itchy but consisted of small bumps (some with what appeared to be clear liquid) with surrounding area being slightly red/pink. * already on Zyrtec (10mg, 3 pills in morning) April 28: Rash did not improve, still very itchy. * Went to clinic, was prescribed Hydroxyzine HCL 25mg (1-2x/day, taken at night) and Triamcinolone Acetonide cream 0.5% (3-4x/day) in conjunction with Zyrtec and Allegra (180mg, 1x/day). April 30: rash had worsened significantly in size, bumps, and redness. Rash still very itchy. * began oatmeal baths, eczema cream with 2% colloidal oatmeal May 10: rash had not improved. Went to dermatologist, had biopsy. Informed to take 20mg Pepcid 2x/day and stop using Triamcinolone. * within a few days of not using Triamcinolone, rash began to improve and become less itchy, less red, and less raised from skin. Continued aforementioned medications and treatments. May 18: rash almost completely gone, areas of breakout no longer pink or raised from skin, itching has mostly subsided.

After 6 days after my first dose of Pfizer I broke out in hives on my elbows and knees. I would wake up with new hives every day on all my joints. After my second dose my hives progressed and ever since has slowly become worse. The hives spread all over my legs and arms and very rarely on my abdomen. These hives will not react to antihistamines .

This is a spontaneous report from a contactable Nurse. A 27-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EJ1686), via intramuscular route administered on Arm Left on 25Jan2021 10:00 AM (27 year-old at the time of vaccination) as single dose for COVID-19 immunization. Patient relevant medical history included anxiety, depression, obsessive-compulsive disorder, post-traumatic stress disorder, bipolar disorder and allergies to PCN, Bactrim, Biaxin, Ceftin, Ceftezole. No other vaccine in four weeks, None other medications in two weeks. No covid prior vaccination, Yes covid tested post vaccination. There were no The patient concomitant medications were not reported. On 26Jan2021 at 08:00, the patient experienced lymph node swelling on affected side, fever, lethargy/fatigue, body aches, bruising and rash to bilateral lower extremities, migraine, nausea/vomiting. The patient underwent lab tests and procedures which included sars-cov-2 test(Nasal Swab) was negative on 28Jan2021. The patient did not receive any treatment for the events. The outcome of event was recovered. Follow-up attempts are completed. No further information is expected.

Shingles: pain in the right left along sciatic nerve. Rash on right buttocks, and on right ankle. Still occurring, it has been 8 days since the pain in my right leg began.

Patient broke out in rash from head to toe covering entire body. No swelling or difficulties breathing. Red, raised, itchy rash. Patient treated with OTC diphenhydramine and aspirin around noon on 5/20/21 with no improvement/worsening of symptoms still at 2:30pm.

The daughter heard a pop; a lot of bleeding after the needle came out; now 2 hours later her arm is numb; The daughter heard a pop; a lot of bleeding after the needle came out; now 2 hours later her arm is numb; Her left arm is warm and numb; This is a spontaneous report from the contactable consumers (including patient's mother) from a Pfizer-sponsored program. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 04May2021 (Batch/Lot Number: EW0171) as 2nd dose, single for covid-19 immunisation. Medical history included mitral valve prolapse. Concomitant medication included metoprolol. The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 13Apr2021 for covid-19 immunisation. The patient received the second dose of the Pfizer COVID-19 vaccine today (04May2021). She received the vaccine in her upper left arm, when they put the needle, she heard a pop. A lot of blood was floating down her arm when they took out the needle. Her left arm is warm and numb. The reporter wanted to know if this will get better and if the vaccine would be effective. It was reported that the nurse had put the shot in left arm and the patient heard a pop and a lot of bleeding after the needle came out and now 2 hours later, her arm is numb. When they pulled the needle in, she heard a pop and when they pulled the needle out, that's when the blood came out and it ran down her arm and now her arm is numb. It's warm to touch but she's feeling that it's numb. They are not sure if she put the shot into the blood vessel or if she went through the blood vessel and they are not sure if it will be affective and if this numbness will dissipate and go away. The patient gets a checkup every year and everything was fine. The outcome of the event was unknown.

Fever of 104 starting at 4am next morning. Chills, body aches. Generalized rash. pain at injection site. Symptoms lasted 12 hours

The patient presented to hospital with anaphylaxis without clear precipitating cause, possibly secondary to Pfizer COVID 19 vaccine. She presented to hospital on 5/22 with a lacy rash over the entire body and a change in her voice with a sensation that she couldn't breathe. She was given several doses of epinephrine, and steroids and improved, and was admitted to medicine for observation. She reported getting initially COVID-19 vaccine dose on 4/19/21. Thereafter had lacy rash over entire body for 3 days which she took as needed benadryl with improvement. After her second dose on 5/10/21 she initially had no symptoms. Approximately 6-7 days after her second dose lacy whole-body rash returned, worse than when she initially had it after first vaccine dose. She took benadryl several times but rash worsened. She had an odd sensation in her throat and noticed a change in the tone of her voice, and felt like she was having difficulty breathing. She presented to the emergency department.

Full body rash - started as hives and ultimately turned into full body rash. Within 5 hours after shot my entire body was covered and completely red/swollen. This rash lasted for a little over a weak.

Hives on wrist, arms, back, stomach, breast, and thighs; Rash; This is a spontaneous report from a contactable other health care professional. A 27-year-old non pregnant female received first dose of BNT162B2 (Pfizer BioNTech Covid 19 Vaccine) (Batch No: EN6199) via an unspecified route of administration, in left arm on 04Mar2021 (at the age of 27-year-old) for COVID-19 immunisation. The patient medical history included hypertension, left ventricular hypertrophy and hypermobility. The patient was allergic to Ciprofloxacin, Sulfa, Ace Inhibitors, Minocycline, Nabumetone and Cefaclor. The patient had not received any other vaccine within 4 weeks of COVID-19 Vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and the patient has not been tested for COVID-19 since the vaccination. Concomitant medications included Bystolic (MANUFACTURER UNKNOWN) and Xyzal (MANUFACTURER UNKNOWN) for an unknown indication. On 11Mar2021, the patient experienced rash and hives on wrist, arms, back, stomach, breast, and thighs. Therapeutic measures included Dexamethasone injection and oral Prednisone which included Doctor visit and emergency room visit. The clinical outcome of the events was not resolved at the time of report. No follow-up attempts are needed. No further information is expected

injection site: redness, swelling, itchy, raised area, very similar to a bee sting/ with the 1st dose, she had a similar reaction and a red spot; injection site: redness, swelling, itchy, raised area, very similar to a bee sting/ with the 1st dose, she had a similar reaction and a red spot; injection site: redness, swelling, itchy, raised area, very similar to a bee sting/ with the 1st dose, she had a similar reaction and a red spot; mild allergic reaction; This is a spontaneous report from a non-contactable consumer (pateint). A 27-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) on 07Apr2021 09:00 as 1st dose, single; then on 06May2021 18:00 as 2nd dose, single; the patient received both doses via an unspecified route of administration on the left arm at the age of 27 years old (Batch/Lot number was not reported) for COVID-19 immunisation. Medical history included mental illness, anxiety, moderate depression, bipolar depression, post-traumatic stress disorder (PTSD), migraines, polycystic ovarian syndrome (PCOS) and sulfa drugs allergies. Concomitant medications included fluoxetine hydrochloride (PROZAC), lamotrigine (LAMICTAL), cetirizine hydrochloride (ZYRTEC ALLERGY), rizatriptan benzoate (MAXALT); all for excendrine migraine. On 07May2021, the patient had injection site: redness, swelling, itchy, raised area, very similar to a bee sting. The patient stated that with the 1st dose, she had a similar reaction on an unspecified date and a red spot about 1 inch wide remained. The patient was treated with ice (as reported), diphenhydramine (BENADRYL) and ibuprofen for mild allergic reaction. The patient had no other vaccines in four weeks and was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Pfizer-BioNTech COVID-19 Vaccine EUA: soon after vaccination patient noted swelling of left external auditory canal that subsequently drained yellow pus. Later in the day the patient noticed facial swelling. Presents to urgent care with fever, headache, nasal congestion, and sore throat. Diagnosed with cellulitis, prescribed topical and oral antimicrobials, advised to manage pain with NSAIDs.

hives; itchy; legs looked as if they were bruised; This is a spontaneous report from a contactable other healthcare professional (patient). A 27-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL8982 and expiration date: unknown), via intramuscular route on 23Feb2021 at 09:00 (at the age of 27-years) as 2nd dose, single dose in left arm for COVID-19 immunization; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP), via an unspecified route of administration on 05Mar2021 (Lot number: unknown), as single dose for immunization; and varicella zoster vaccine (VARICELLA VACCINE), via an unspecified route of administration on 05Mar2021 (Lot number: unknown) as single dose for immunization. The patient medical history included: attention deficit hyperactivity disorder (ADHD), gastrooesophageal reflux disease (GERD), and anxiety. No other vaccine in four weeks. Concomitant medications included: amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), sertraline hydrochloride (ZOLOFT), and omeprazole magnesium (PRILOSEC). The patient previously received first dose of BNT162B2 (lot number: EL9261) on 02Feb2021 at 09:15 (at the age of 27-years) via intramuscular route as 1st dose, single dose in left arm for COVID-19 immunisation and Bactrim for an unspecified indication and had known allergies. Prior to the vaccination the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. On 06Mar2021 at 12:00, the patient experienced hives, itchy, and legs looked as if they were bruised. The events resulted in visit to emergency room/department or urgent care. Clinical course of the events included: she got a Tdap and Chicken pox vaccine on Friday 05Mar2021 which was before the two weeks mark of her second COVID vaccine. The pharmacist did not ask if she had gotten any shots beforehand so she completely forgot that she probably should not have gotten these vaccines. She ended up having an allergic reaction to these vaccines. She broke out in hives, got itchy, and her legs looked as if they were bruised. She was told to report this by the emergency room (ER) staff and her pharmacist. The events were treated with methylprednisolone tablets. Since the vaccination the patient had not been tested for COVID-19. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected. ; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events hives, itchy and the suspect drug BNT162B2. Also, there is limited information in the case provided, the causal association between the event contusion and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.

Body aches; Headache; Nausea; Fever; Dizziness; Injection site pain; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: unknown), via an unspecified route of administration in the left arm on 17May2021 at 17:30 (at the age of 27-years-old), 2nd dose, single, for COVID-19 immunization. Medical history included bronchitis, COVID-19, penicillin allergy and exercise endured asthma. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: unknown) administered via an unspecified route of administration on 26Apr2021 at 17:30 (at the age of 27-years-old), 1st dose, single for COVID-19 immunization. Prior to vaccination, the patient was diagnosed with COVID-19 but did not receive other vaccines four weeks prior. The patient was not pregnant at the time of vaccination. The vaccine was administered at a pharmacy or drug store. On 18May2021 at 09:00, the patient experienced body aches, headache, nausea, fever, dizziness, and injection site pain. The events were reported as non-serious. The patient received unspecified over the counter medication and nurse directed to take rest. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was recovering. Information on the lot/batch number has been requested.

This is a spontaneous report from a non-contactable consumer. A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 07Feb2021 at single dose for COVID-19 immunization at the age of 27-year-old. Medical history and concomitant medications were unknown. On 08Feb2021, the patient experienced soreness at injection site; no treatment given for the event. The patient recovered from the event. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

recurrent idiopathic hives since being vaccinated; recurrent idiopathic hives since being vaccinated; numbness in arm and face for 2 hours after vaccination; Pain when breathing 8 hours after vaccine; This is a spontaneous report from a non-contactable consumer (Patient). A 27-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number was not reported) via an unspecified route of administration on 24Feb2021 (at the age of 27-year-old) as single dose for COVID-19 immunization. Previously patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number was not reported) via an unspecified route of administration in left arm on 21Jan2021 as single dose for COVID-19 immunization.Medical history included psoriatic arthritis, idiopathic autoimmune hives, allergies to bactrim, penicillin, peanuts, shellfish, watermelon. Concomitant medications included Humira, prednisone, Zyrtec. It was reported that 1st dose facial numbness for 13 hours 2nd dose numbness in arm and face for 2 hours after vaccination. Pain when breathing 8 hours after vaccine Now have recurrent idiopathic hives since being vaccinated. AE treatment allergy medication included epi pen, allergy testing. Patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Patient has not been tested for COVID-19 post the vaccination as well as prior to vaccination. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.

Severe pain in arm that received injection and pain throughout entire body. Increase in involuntary muscle spasms and twitches. Pain was at an 8 on 0-10 scale. Whole body aches, exhaustion.

I experienced a small itchy/red rash on the forearm of the arm I was vaccinated. My identical twin sister, who has the autoimmune disorder also experienced an allergic reaction but more severe. She experienced hives 5-6 days following her Maderna vaccine

Day 1: pain at injection sight, mild headache, resolved with ibuprofen. Day 2: menstruation occurred 2 weeks early, moderate bleeding, moderate uterine cramping, muscle pain, severe fatigue. Day 3-5: menstruation continues, moderate bleeding severe fatigue, extreme thirst.

his wife started loosing her hair 4 days after the administration of the vaccine; as a consequence she is anxious and depressed.; as a consequence she is anxious and depressed.; This is a spontaneous report from a contactable consumer (patient's husband). A 27-years-old female patient (reporter's husband) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number was not reported), via an unspecified route of administration on 05May2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date in May2021, patient experienced his wife started loosing her hair 4 days after the administration of the vaccine and as a consequence she is anxious and depressed. It was reported that a reporter called on behalf of his wife for information about if losing hair is a side effect for the administration of the Pfizer's COVID-19 vaccine and information about if it would be safe to be administered with the second dose of the Pfizer's COVID-19 vaccine after loosing her hair possibly as a side effect for the administration of the vaccine. The reporter was going to speak with his Physician for more information and management. Reporter called on behalf of his wife for information about the maximum timeframe for the administration of the second dose of the Pfizer's COVID-19 vaccine. There was no PQC (product quality complaint) present. The outcome of both event was unknown. Information on the lot/batch number has been requested.

Small white oval area around vaccination site, also slight swelling at first a day or two post vaccination. Continues to be a white area despite tanning around area on arm. No swelling at present time 3 weeks post 1st vaccine dose.

Client states that after her 1st dose Pfizer COVID vaccine (LOT: EW0179, Expiration 08/31/2021) received 05/06/2021 she developed a bilateral inner arm and belly rash during her 15 minute observation period. She reported she did not alert the EMTs at the time but left the site and went home to take a 25mg Benadryl. She stated the symptoms resolved approximately 1.5 hours after taking the Benadryl and did not return She denied any other symptoms such as chest pain, shortness of breath, facial swelling, tongue, mouth, throat swelling or tingling. She reported positive for an anaphylactic reaction to strawberries, but otherwise denied allergies to any other medications/foods/environment. She denied any other significant medical history or medication use.

Many many balls in both hands. No itching, no burning, and after the medications my hands completely peeled off and it's still like that.

Patient reported having hives in two places (left thigh and left flank), hot face (not noticeably red), shortness of breath, pulse 68, BP 118/76; occurred within 15 mins of immunization, Benadryl 50 mg PO capsule x1 dose was administered and all symptoms resolved (per patient report) within 10 minutes. She reported a history of similar reactions, resolved using Benadryl. She also carries an epi pen and has one at home if needed.

Inflammation at vaccination site; Arm vaccinated sore; Fever; lethargy; aches in joints; chills; light-headedness; congestion; headache; soreness; This is a spontaneous report contactable consumer or other non HCP (patient, self-reporting). A 27-year-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EN6206 and expiration dates was not reported), via an unspecified route of administration in left arm on 03Mar2021 at 14:30 as second dose, single for COVID-19 immunisation. The patients medical history included diabetes, PCOS, sciatica, scoliosis, psoriasis on an unknown date. Concomitant medication included LPRYNA 0.02MG two weeks. The historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EM9810 and expiration dates was not reported), via an unspecified route of administration in left arm on 10Feb2021 at 14:30 first dose single for COVID-19 immunisation. On 03-MAR-2021 23:45 patient experienced Inflammation at vaccination site. Arm Vaccinated sore. Fever, lethargy, Aches in joints, chills, light-headedness, Congestion, headache, soreness. Patient did not have any vaccines prior to four weeks. Facility type vaccine: School or student health clinic. There was no treatment given for the adverse events. No COVID prior vaccination and did not tested COVID post vaccination. Outcome of the events were recovering. No follow-up attempts are possible. No further information is expected

IMMEDIATLY I BROKE OUT IN HIVES ALL OVER, MY RIGHT ARM SWELLED UP, AND HOT TO THE TOUCH, COULD NOT SWALLOW, AND LOST MY VOICE. IT STARTED CALMING DOWN AN HOUR AFTER I WAS GIVEN STERIODS.

feel very tired; pain at the injection site; feel very thirsty; This is a spontaneous report from a contactable consumer (patient herself). This 27-Year-old female consumer reported for herself that received BNT162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number and expiry date Unknown) via an unspecified route of administration in left arm on 08Mar2021 16:30(at the age of 27-years-old) as unknown, single dose for COVID-19 immunisation. The patient was not pregnant. Medical history included depression and anxiety. Patient was allergic to zyrtec, adhesives. Concomitant medications included vortioxetine hydrobromide (TRINTELLIX), ethinylestradiol, norgestimate (ESTARYLLA), doxylamine succinate (UNISOM [DOXYLAMINE SUCCINATE]), Ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No other vaccines in 4 weeks. On 09Mar2021 08:15 (Timeframe between vaccine start and event onset date was 15 hrs 45 min) patient experienced feel very tired, some pain at the injection site, and feel very thirsty. Therapeutic measures were not received as a result of adverse events. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.

Redness, swelling, hardness, and warm to touch at injection site approximately 19 hrs following vaccination. Pt also had chills/body aches/headache that resolved quickly. Redness continued, and area is growing. Pt is seeking medical attention at this time. Pt has contacted PCP but is awaiting appointment.

1st Dose Reactions-Fatigue/Tiredness: occurred two days after injection for four consecutive days & Injection Site Pain: occurred for 48hrs after injection 2nd Dose Reaction-Appendicitis: occurred four days after injection

Pt presents w/ redness to eye, "spots" to eye area 20 mins after vaccination. No visual disturbances. No respiratory issues. No swelling. NKDA, No PMH or medications. BP 114/74, HR 81, RR 18

Dry sick; Felt drunk out of my mind; Felt like had pneumonia or the flu; Injection site pain; Tiredness; Headache; Muscle pain; Chills; Nausea; Feeling unwell for about five days; Diarrhea; Vomiting; Arm pain; Felt like had pneumonia or the flu; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 26May2021 10:30 (at 27-year-old) (Batch/Lot Number: EW0171) as 1st dose, single in arm left for COVID-19 immunisation. It's unknown if the patient was pregnant. The patient's medical history and concomitant medications were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No known allergies. On 26May2021, injection site pain, tiredness, headache, muscle pain, chills, nausea, feeling unwell existed for about five days; and diarrhea, vomiting, arm pain occurred. It's felt like had pneumonia or the flu. Side effects hit her later that night about 9pm and she felt drunk out of her mind by 10:30 pm dry sick. No treatment received for the events. Since the vaccination, the patient hasn't been tested for COVID-19. The outcome of the events was resolving. No follow-up attempts are possible. No further information is expected.

had a few welts on my left arm where the vaccine was administered; Entire body was broken out in a rash/on my entire body head-to-toe/The rash is very itchy and sometimes oozes clear liquid; Entire body was broken out in a rash/on my entire body head-to-toe/The rash is very itchy and sometimes oozes clear liquid; Entire body was broken out in a rash/on my entire body head-to-toe/The rash is very itchy and sometimes oozes clear liquid; This is a spontaneous report from a contactable consumer (patient). A 27-year-old-female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN6203) via an unspecified route of administration, administered on the left arm on 25Feb2021 14:15 as 1st dose, single for COVID-19 immunization. Medical history included eczema an Allergy to Propylene Glycol. Concomitant medication included birth control pills. After receiving the first dose of the vaccine, patient had a few welts on her left arm where the vaccine was administered about an hour after the vaccine on 25Feb2021. About 3-4 days later (Feb2021), she noticed my entire body was broken out in a rash. The rash was very itchy and sometimes oozes clear liquid. She used steroid cream, creams, allergy medication, but the rash has not went down. It was on her entire body head-to-toe and has been here for 2 and 1/2 weeks with no sign of improvement. No treatment was received. Patient was not pregnant at the time of vaccination. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered.

Arm started feeling really sore where the shot was injected, I then started feeling a very sore throat, I lost my voice, my stomach ached pretty bad. Over a course of 4 days I noticed the symptoms listed were getting worse. About an hour and a half ago, my symptoms started to go away on their own.

Severe rash to the trunk, arms, legs, scalp, and back. Steroid shot of steroid to the hip to treat rash. Prescribed predinsone for 5 days.

I expected the body aches. But now my arm at the injection site had a 2in knot and is warm to touch and itchy. The knot is extremely painful and staying active and working out the arm did not help.

She stated that she was vaccinated with her second Covid vaccine at around 0800 on 9 June. She stated that she immediately felt shoulder numbness and she informed the vaccine administrator who told her that this was normal. Patient reported that she was sitting and vaccinator was standing and that she thought that the shot was administered high on her shoulder. Pt reported that around 1130-1200 hrs the numbness started to ease but that is when the pain and weakness started. She reported increase pain when she tried to raise her arm. It was painful at night and she began to have muscle spasms in her upper back. She also reported arm weakness. She went to her PCM who told her that her symptoms may be SIRVA. She was prescribed a muscle relaxant that helped. Asked about steroids and pt reported that she is allergic to prednisone. She stated that the pain and weakness continued until the 17 Jn and since that time she is only reporting a little soreness. Symptoms: PARESTHESIA OF SKIN, PAIN IN UNSPECIFIED JOINT.

Immediately following vaccine & last three days was a deep soreness in the arm of the injection site. This side effect was anticipated. However, since then, what feels like a tightness or pinched nerve sensation has continued in that arm. It has been over one month since the vaccination. It is mildly painful to raise that arm. No degree of stretching or exercise has relieved this pain. My concern is that it may be permanent.

Developed 2 pink maculopapular nonpruritic rashes on right breast and right buttock. She still has them today and they appear to be pityriasis rosea. This initial rash appeared 2 days after her second vaccine. 2 weeks after, she developed what she describes as hives that were not pruritic and were not visible to the eye but can be felt on her skin. They resolved on their own and are not present today. She occasionally will get the pink maculopapular rashes appearing on her trunk still. No treatment.

Fever of 103.1; Cold Chills; Body Ache; Pain At Injection Site; Very Tired, Extremely exhausted; Delusional off/On; Mild/Sever Diarrhea; Headache On/Off; Upset stomach; Loss of appetite; Lazy Feeling(Extremely exhausted); Left arm swelling arm & Injection Site; Left arm swelling arm & Injection Site; left arm pain, very red tender to touch; Very red tender to touch; This is a spontaneous report from a contactable consumer (patient). A 27-years-old female patient received bnt162b2 via an unspecified route of administration, administered in left arm on 10Jun2021 11:00 (Lot Number: Ew0180) as 2nd dose, single dose at the age of 27-year-old for covid-19 immunization. The patient was not pregnant. Historic vaccine was bnt162b2 via an unspecified route of administration, administered in left arm on 17May2021 13:45 (Lot Number: Ewv172) as 1st dose, single dose at the age of 27-year-old for covid-19 immunization. Medical history included Lung disease- Histoplasmosis, Stress Seurizes, chronic back pain, and Known allergies: Adhesive tape from an unknown date. Past drug event included ibuprofen and doxycycline and experienced allergies. Concomitant medication included cetirizine hydrochloride (CETIRIZINE HCL); oxycodone hydrochloride, paracetamol (PERCOCET, 5 mg); women vitamins (OLLY), all taken for an unspecified indication within 2 weeks of vaccination. The patient experienced left arm swelling arm & injection site, very red tender to touch/left arm pain, cold chills, body ache, pain at injection site, very tired, delusional off/on, mild/sever diarrhea, headache on/off, upset stomach, loss of appetite, lazy feeling (Extremely exhausted) on 10Jun2021. The patient also experienced fever of 103.1 on 10Jun2021 11:00 am. The patient underwent lab tests and procedures which included body temperature: 103.1 on 10Jun2021 11:00 am. Therapeutic measures were not taken as a result of events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was not recovered.

Started on the morning of 6/25/2021. I received my second dose of Pfizer COVID vaccination after my menstrual period ended and this morning when I woke up, I noticed that there was blood on the toilet paper. There was no blood in the urine and throughout the day, there continues to be an increase in the amount of blood left on my pad and tissue paper. Haven't had issues with spotting in the past and this is a new occurrence. Also feel that my left posterior auricular lymph node is harder and more swollen and left sinus is more congested.

A week after my first vaccine I started developing hives all over of my body. I would get them about 2-3 times a week.; This is a spontaneous report from a contactable consumer or other non hcp. A 27-years-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot Number: EL9266 expiry date was not reported) as dose 1 via an unspecified route of administration, administered at Arm Left on 13Feb2021 as a single dose (age at avccination was 27-years-old) for COVID-19 immunisation. Patient's medical history reported as none. The patient's concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have known allergies. The patient no other vaccine in four weeks. The patient had not received other medications in two weeks. The patient experienced a week after first vaccine she started developing hives all over of patient body and she would get them about 2-3 times a week. She went to an allergist and she cannot diagnose (urticaria) (disability). Therapeutic measures were taken because of a week after my first vaccine she started developing hives all over of my body. Patient received treatment of Allegra twice a day and Zyrtec. She would get them about 2-3 times a week. The outcome event was not recovered. Information is needed. Further inform is requested.

Red dots all over the body including face, arms, neck, legs. Also a big rash at the place of injection

The skin on my back got extremely sensitive to everything.; Skin sensitivity on my back - felt like Ihad been badly sunburned. There was no visibleredness or swelling but everything thattouched my back stung.; This is a spontaneous report received from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration in the left arm on 20Mar2021 at 1045 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 6198) via an unspecified route of administration in the left arm on 27Feb2021 at 1045 as a single dose for COVID-19 immunisation. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. The patient did not receive any concomitant medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 2100, the patient reported that she had skin sensitivity on her back which felt like badly sunburned, the skin on back got extremely sensitive to everything. There was no visible redness or swelling, but everything that touched her back stung. It was reported that no treatment was taken for the events experienced. The clinical outcome of the event skin sensitivity which felt like badly sunburned and everything that touched her back stung was resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

knot in arm where shot was injected; Red spot on arm; This is a spontaneous report received from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration in left arm on 20Mar2021 at 08:15 (at the age of 27-year-old), as a single dose, for COVID-19 immunisation. Concomitant medications included vitamin D (MANUFACTURER UNKNOWN), ZOLOFT, XANAX, biotin (MANUFACTURER UNKNOWN), buspiron (MANUFACTURER UNKNOWN) and AIMOVIG. The patient had history of drug allergy to Zofran. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. On 20Mar2021 at 21:00, the patient experienced red spot-on arm (vaccination site erythema) and a knot in arm where shot was injected (vaccination site mass). No therapeutic measures were taken as a result of adverse event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of events vaccination site mass and vaccination site erythema was not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

Dizziness; Runny nose; Weakness; Exhaustion/ Fatigue; Injection site itchiness; Face and arm itchiness; Headache; This is spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration in the right arm on 18Mar2021 at 15:45 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, allergies (unspecified) and obesity. It was provided that the patient was not allergic to medications, food, or other products. Concomitant medications included Zyrtec, trazodone (MANUFACTURER UNKNOWN), D3 (MANUFACTURER UNKNOWN), B12 (MANUFACTURER UNKNOWN), vitamin C (MANUFACTURER UNKNOWN) and fish oil (MANUFACTURER UNKNOWN). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Since the vaccination, the patient was not tested for COVID-19. On 18Mar2021 at 18:00, the patient experienced exhaustion, fatigue, dizziness, weakness, injection site itchiness, face and arm itchiness, runny nose and headache. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic treatment was taken for the reported events. The clinical outcome of the events exhaustion, dizziness, weakness, injection site itchiness, face and arm itchiness, runny nose and headache were resolving at the time of this report. No follow-up attempts are needed. No further information is expected.

Swelling in arm, redness previously, Chest pains on the 29th , and this morning had problem with breathing and temp 103.9.

Light-headed; Skin pink; Dry skin; Skin warm; Nausea; Heartbeat everywhere; This is a spontaneous report from a non-contactable healthcare professional for patient. A 27-year-old female patient of unknown pregnancy received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204), via intramuscular route of administration on 06Mar2021 at 14:00 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were denied. The patient previously received morphine (MANUFACTURER UNKNOWN) and amoxicillin (MANUFACTURER UNKNOWN) for unspecified indication and experienced drug allergy (unknown reaction). Prior to vaccination, it was unknown if the patient had symptoms associated with COVID-19. Since vaccination, it was unknown if the patient was tested COVID-19 positive. It was unknown if the patient received any other vaccines within 4 weeks. On 06Mar2021 at 14:05 (approximately 5 minutes post vaccination), the patient experienced light headedness and nausea. The patient was able to feel the heartbeat everywhere (palpitation). The patient was alert and oriented and was further noted with skin pink, warm and dry. The patient was placed on gurney and assessed by emergency medical services and physician on duty and was continued observation in first aid area. The patient was given water and was reported that symptoms were improving. The patient was cleared for to discharge home by physician on duty. The patient did not receive treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events dry skin, light-headed, nausea, skin pink, skin warm and palpitation was recovered on 06Mar2021 at 14:41 (able to sit upright without symptoms). No follow-up attempts are needed. No further information is expected.

pain at injection site; Muscle soreness on back and hips.; feeling too hot and too cold; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old non pregnant female patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number; EL3247) via an unspecified route of administration in the right arm on 22Mar2021(at the age of 27 years) at 12:00 as a single dose for COVID-19 immunisation. No medical history was reported. Concomitant medication included birth control. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number; EL3247) via an unspecified route of administration in the left arm on 01Mar2021 (at the age of 27 years) at 14:15 as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, patient was not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Mar2021 at 23:00, patient experienced pain at injection site, muscle soreness on back and hips and alternating between feeling too hot and too cold. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment for the events were not reported. The clinical outcome of the event pain at injection site, muscle soreness on back and hips and alternating between feeling too hot and too cold were recovering at the time of report. No follow-up attempts are needed. No further information is expected.

103 fever; chills; cold sweats; Injection arm was so sore; shocks; dizzy; severe increase in heart rate; This is a spontaneous report from a contactable consumer, the patient. A 27-years-old non pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the right arm on 23Mar2021 at 10:15 (at the age of 27 years) as a single dose for COVID-19 immunisation. Medical history included ITP (idiopathic thrombocytopenia purpura). Concomitant medications reported as no. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021, immediately following injection, the patient experienced severe increase in heart rate. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On same day at 22:00 within 12 hours after vaccine, the patient experienced a 103 fever with chills and cold sweats, injection arm was so sore that the patient could not move it at all without severe pain. When patient tried to sleep, she had shocks every 15 to 30 minutes throughout the body. The fever continued for 36 hours including the fever, chills, and shock. The patient was dizzy the entire time with trouble standing. No therapeutic measures were taken for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient underwent lab test body temperature measurement on 23Mar2021 and the recording was 103 (unspecified units). The clinical outcome of the events increased heart rate, fever, chills, cold sweat, vaccination site pain, electric shock sensation and dizzy was resolving at the time of this report. No follow-up attempts are possible. Information about lot/ batch number cannot be obtained.

within 10 minutes of vaccine patient started to have itching on body. I gave 50mg Benadryl and called 911. pt was assessed by ems and all vitals were stable at that time. pt refused transport to ER.

bruise from first dose; This is a spontaneous report received from a contactable consumer reported for a female patient. The consumer reported on two patients one is husband and one is wife. Report 1 of 2. This is the report on the wife. This report was not related to a study or programme. A 27-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0217; Expiration Date: Sep2021), via an unspecified route of administration, administered in Arm Left on 04Jun2021 (at the age of 27-year-old), as single for covid-19 immunisation. Medical history included anaemia. Family medical history relevant to events was none. The patient concomitant medications were not reported. Additional Vaccines administered on Same date of the Pfizer Suspect was none. The patient did not receive other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The events following prior vaccinations were none. On 18Jun2021, the patient experienced bruise from the first dose. Reporter stated that patient had a bruise from the first dose, but it was starting to fade, it was non concerning. The event did not require a visit to emergency Room and Physician office. The relevant tests were none. Reporter stated that the patient was in the hospital recently, but it was for a panic attack due to a paperwork issue as far as the reporter know. The patient was resolving from the event at the time of this report. Follow up needed, further information has been requested.; Sender's Comments: Linked Report(s) :PFIZER INC-2021810425 Same reporter/ drug, different patient/ AE

Itching all over my body started 2 days after my second dose of the covid vaccination. There are no rashes and no itching at the injection sight, but my entire body has been itching since Friday June 25th 2021 and still itches today on July 11th 2021.

Rash around my upper body; Itchy; This is a spontaneous report from a contactable consumer (patient). A 27-year-old female patient received the first dose of BNT162B2 via an unspecified route of administration on the left arm on 08Jun2021 (Lot Number: EW0186; Expiration Date: Unknown) at the age of 27-year-old as single dose for COVID-19 immunization. Medical history and concomitant medication were none. Prior Vaccinations (within 4 weeks), the patient stated none. Investigation assessment was none. On 24Jun2021, after 16 days after the first shot, the patient experienced rash around upper body and it was not just around the vaccine site, the patient became itchy and was just wondering if anybody else has these side effects and wanted to check if anybody else had something similar to that. And both event serious as medically significant. The patient took a Claritin, and an allergy medication, antihistamine Claritin pill as treatment for events. The patient stated that it could be totally unrelated to the vaccine. The scheduled date for second dose will on 30Jun2021. The outcome of events was not recovered.

About 4-5 hours after my shot, my left leg was tingling (like if I sat on it wrong) for about a day and a half; then felt chest pressure; got muscle twitches; all subsided within the next few days. About 10 days afterwards (on 6/28), I had to go to the ER because got a sharp pain in my left upper arm (felt like a nerve issue), pain was a 10/10, ibuprofen did not help, so had to press ice packs really hard which helped a little bit. The pain started in my left arm then the next day went to my left arm and left foot, then the next day went to left arm and foot and then my right upper arm in the same spot as the left; pain continued to decrease within 5 days. At the ER the did a blood test, ECG, chest xray, and urine test and said that all came back normal and blood pressure was fine. I was fine for about a week and is now the pain started coming back (7/10) but the pain is a 1/10. This all happened after my 1st dose so I'm undecided on if I'm going to get the 2nd shot because I'm terrified of the initial pain coming back. Currently waiting for lab results from a local doctor.

I experienced itching and tingling in my mouth, throat and ears. A red rash could be seen on the roof of my mouth down my throat. This has happened three times since getting the shot and I have never experienced this before. Symptoms resolved with benadryl.

PATIENT REPORTED ON 7/13/21 THAT SHE HAD TO GO TO AN URGENT CARE AND SHE WAS PRESCRIBED ANTIBIOTICS DUE TO SKIN INFECTION AT INJECTION SITE

Hours after receiving the vaccine I felt as though I had a headcold with the severity of my symptoms decreasing day-by-day for about eight days. The ninth day, after my "headcold" symptoms had abated; I started finding itchy hives first on my left arm, the left side of my back, and the left side of my upper stomach. The next day the hives has spread to my scalp, face, ears, left hand, groin, left leg, the upper parts of both my right arm and right leg, the right side of my back, and most of my torso.

Developed a small rash (red itchy bumps)1 week after covid vaccine. 2 weeks later it spread down my arms, legs and torso. Seems to go away with antihistamines, the reactions happen off and on.

To, The Centers for Disease Control and Prevention The patients. I am a 27-year-old female residing since August 2019. I am a Resident and an immigrant. On the 20th of April, 2021 I took my first shot of the Pfizer-BioNTech COVID-19 vaccine in where I reside. After 48 hours of taking the vaccine, I started experiencing extreme fatigue, dehydration, and chills. I also registered a fever of close to 101 on a few nights in the week after. I thought this was a temporary side-effect of the vaccine, but the side-effects persisted and was not dying down. Over the next 2-3 weeks my health condition waxed and waned. I was facing extreme fatigue to the extent it had disrupted my normal life, heavy dehydration, loss of appetite, feeling cold easily, especially in the evenings. I called up the center and asked if I could delay my 2nd COVID-19 Pfizer shot, but because it is generally advised to take the second shot within a 28-day period in the United States, I decided to go ahead and take my second shot on May 14th. I took a couple of Acetaminophen tablets this time to help reduce a possible fever. Over the next weeks, my condition did not seem to change, even though I was done with both my shots. I continued to face fatigue and weakness, I had lost 10-11 pounds, a huge loss in appetite, I started noticing heavy hairfall daily. My period had not come since taking the vaccine. In the early month of June, I noticed dark red blotchy marks that had appeared on both my arms. My health started deteriorating heavily in June, there were days when I could sleep all day. I started noticing a fever which climbed to 101-102 daily, especially in the evenings and continuous shivering. Seeing the signs of a serious medical condition, I filed for emergency leave from my workplace and decided to fly back to India where my family resides. I landed in the 30th of June, 2021. I was admitted to a hospital in the Emergency Unit on the very same day and where I continued to remain hospitalized until the 9th of July. I was hospitalized for a period of 10 days, during which multiple blood tests, scans and procedures were run on me, at the end of which I was diagnosed with now having a chronic illness, an Autoimmune disorder called Systemic Lupus Erythematosus. I am currently, recouping from my illness and undergoing treatment for SLE. I do not know if there was a correlation between my taking this vaccine and the triggering of my illness, but if there is a possibility of the vaccine triggering an Autoimmune disorder in healthy individuals, I would like the concerned authorities to make a note of it. Symptoms: Extreme Fatigue, Continuous High Fever, Heavy Hairfall, Loss of Appetite, Feelings of Nausea, Red marks on arms, Weight Loss, No menstruation

Fever from time woke up on the 18th until went to sleep on the 19th. Shoulder is red and inflamed with goosebumps on it started at same time as fever and is growing larger still swollen on the 20th at 7pm

Patient stated that she had an allergic reaction to fist dose of Pfizer Vaccine, Patient stated that she has hives all over her body. Patient states that reaction started of 06/27 and has gotten worse, she visited her doctor. Patient was prescribed cream and steroid for relief and neither has worked.

Body aches; soreness at injection site; lumps in left armpit; slight fever; This is a spontaneous report from a contactable consumer. A 27-years-old non-pregnant female patient received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247), dose 2 via an unspecified route of administration, administered in Arm Left on 18Feb2021 13:15 (27-years-old at the time of vaccination) as DOSE 2, SINGLE for covid-19 immunisation at workplace clinic. Patient is not pregnant at the time of vaccination. The patient medical history was not reported. Concomitant medication included norethisterone acetate taken for contraception, start and stop date were not reported. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included bnt162b2 (PFIZER COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3247), dose 1 via an unspecified route of administration, administered in Arm Left on 28Jan2021 11:00 AM for covid-19 immunisation. On 19Feb2021 09:00 the patient experienced body aches, soreness at injection site, lumps in left armpit, slight fever. Patient did not receive any treatment for adverse events. The clinical outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

After 30 minute wait time was over patient started to feel itchy around 1740, we gave the pt 25 mg Benadryl at that time. Pt HR 88 regular, oxygen 99%. Pt. reports tightness in chest around 1746. 1755 Pt. reports headache. 1800 itching is gone, chest tightness continues, pt. is now coughing.

Nausea; diarrhea; headache; injection site pain; injection site swelling; chills; fever; joint pain; tiredness; This is a spontaneous report from a non-contactable consumer, the patient. A 27-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Mar2021 at 14:45 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient did not have any allergies to medications, food, or other products. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on unknown date as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 07:00 the patient experienced nausea, diarrhea, headache, injection site pain, injection site swelling, chills, fever, joint pain and tiredness. The events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On an unknown date, the patient received TYLEX as a treatment for the events. The clinical outcomes of the events nausea, diarrhea, headache, injection site pain, injection site swelling, chills, fever, joint pain, tiredness were resolved on an unknown date in 2021 at the time of report. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

she was fighting tonsil infection or strep from what doctors assume; she was fighting tonsil infection or strep from what doctors assume; hair started to fall out; had every type of COVID symptom; vomiting; fevers; chills; sore throat; tiredness; headache; sleep apnea; pregnant at time of vaccination/ gestation period were 31 weeks; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 27-years, via unspecified route of administration at single dose for COVID-19 immunization, first dose in left arm on 25Jun2021 at 12:00 and second dose on unspecified date. Medical history included tonsillitis, functional neurological disorder with clink rare genes with child, GERD, autism. The patient was pregnant at time of vaccination. Patient last menstrual period date was 10Dec2020 and pregnancy due date 09Sep2021, gestation period were 31 weeks. No other vaccine in four weeks. No known allergies. No COVID-19 prior vaccination. Concomitant medications included prenatal (unspecified), folic acid, antibiotics. The patient reported that after her first and second dose her hair started to fall out. She was fighting tonsil infection or strep from what doctors assume. She probably should of waited until she was done taking her penicillin anti biotic. She had every type of COVID symptom but doctor was surprised to find no illnesses to explain her vomiting, fevers, chills, sore throat, tiredness, headache, etc. She saw a tonsil doctor to set up future removal. And sleep apnea testing. Adverse event start date on 20Jun2021 (as reported). Adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment received. No COVID-19 tested post vaccination. Outcome of the events was not recovered. Information about batch/lot number has been requested.

I got the vaccine on 4/14, the next day I had arm soreness and heaviness. That lasted about 2 days. Not long after, I started getting a rash on my jaw neck throat shoulder s and chest are. I had a bump near the injections site. I was diagnosed by 2 dermatologists with acneiform rupture. Within a week of the 2nd dose, I saw a dermatologist who diagnosed me with that. I saw another doctor on 4/22 who agreed with the initial diagnosis. It eventually got better. I was prescribed a topical foam which did not completely help.

Developed a rash that started on my chest and forearms and is spreading throughout most of my body. It is slightly raised on my skin and minorly itchy in places, but not unbearable.

Short term reaction (within 10 minutes of administration) red blotchy rash on neck and chest. Warm to touch. This is a common event for me and is believed to be related to the chronic hives. Did not happen on the second dose. Longer term (started within a day, took months to recognize): significant worsening of existing diabetes insipidus that cleared up upon stopping all lithium. This was done in June.

Patient reported feeling numbness in arm, generalized itching all over body, dizziness. Patient was given (2) Diphenhydramine 25 mg tablets and water. EMS was contacted due to numbness and generalized itching including the lips. EMS arrived worked up the patient and determined the patient was doing well after approx. 30 minutes. The patient declined going to the hospital for further follow-up.

Itching has gotten worse/tips of her ears felt inflamed and were itchy/The itching was so unbearable at times it waked her up at night from sleep; Hives; Bumpiness; Redness; Tips of ears inflamed and are itchy; I have bruised myself from itching my arms; This is a spontaneous report from a contactable other health care professional (patient) reported for herself. A 27-year-old non-pregnant female patient received bnt162b2, dose 2 via an unspecified route of administration, administered in left arm on 27Mar2021 17:00 (at the age of 27 years old) (Batch/Lot Number: EP7534) as single dose for covid-19 immunization. Medical history included known allergies as Penicillin-related antibiotics. Concomitant medications within 2 weeks of vaccination included colecalciferol (VIT D3) and cyanocobalamin (VIT B12). The patient previously received bnt162b2, dose 1 via an unspecified route of administration, administered in left arm on 02Mar2021 12:00 PM (at the age of 27 years old) (Batch/Lot Number: EN6202) as single dose for covid-19 immunization and experienced Itchy arms, red dots, Itching on arms progressively got worse, petechiae. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. 1-2 weeks after first dose, started having itchy arms - didn't think much of it because it would go away. Around the same time, red dots started forming around her ankles up to her lower thighs - not raised or itchy. Itching on arms progressively got worse. Went to the doctor and she attributed it to the vaccine. Rx'd Triamcinolone Cream and checked platelets for possible petechiae on her legs - platelets were normal. Said it was ok for her to get second dose. Itching had gotten worse. Itching leads to hives, bumpiness, and redness. Had spread from arms to legs to torso over last few weeks. At time of report, the tips of her ears felt inflamed and were itchy. The only thing that had somewhat helped was diphenhydramine hydrochloride (BENADRYL). Creams/lotions did not help. The red dots were still present, but more local to her ankles. The itching was so unbearable at times it waked her up at night from sleep. The patient bruised herself from itching her arms. Date of start of reaction/events was Mar2021. Ae resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included platelet count: normal in Mar2021, covid test (Spit test): negative on 30Mar2021 (Nasal Swab). The outcome of events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021367775 same patient/reporter, different AE/dose

Hives on my cheeks; Flushing within 10 minutes; Flushing within 10 minutes where my face and neck became really hot feeling to me and to touch.; This is a spontaneous report from a contactable consumer (patient). This consumer reported 2 reports for same patient and different dose, this is the first of 2 reports. A 27-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 05May2021 at 15:30 (Batch/Lot Number: EW0179) at age of 27 years old as DOSE 1, SINGLE for covid-19 immunisation. Known allergies included patient was allergic to Tylenol and environmental allergies like dust, dogs, mold, trees and weeds. Other medical history included patient had Irritable bowel syndrome (IBS-D), anxiety, and Obsessive-compulsive disorder (OCD). Patient had had a colonoscopy, and laparoscopy to break apart an abdominal adhesion she had. The concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The first time patient got the vaccine she had flushing within 10 minutes (as reported) where her face and neck became really hot feeling to she and to touch. Patient thought she was just warm in her mask but when she got to her car, patient could see it all and there were hives on her cheeks. Patient ended up taking BENADRYL which cleared it up. Patient saw an allergist between vaccines who told she to take ALLEGRA and PEPCID one hour prior to the second vaccine (and patient also retested miralax). Adverse event started on 05May2021 at 15:45 PM (as reported). The adverse event result in doctor or other healthcare professional office/clinic visit. The treatment received for the adverse event included BENADRYL. The outcome of event flushing within 10 minutes was recovered in 2021, of other events was recovering. Follow-up attempts completed. No further information expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021627027 same patient/reporter/drug, different dose and different AE in separated time

Allergic reaction (non-life threatening) where I had itchy eyes, nose, throat, and neck; Allergic reaction (non-life threatening) where the patient had itchy eyes, nose, throat, and neck; eyes were burning; felt very hot; soreness in the right arm (where the shot was given); This is a spontaneous report from a contactable other healthcare professional. A 27-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 3248) via an unspecified route of administration in the arm right on 27Apr2021 at 10:00(at the age of 27-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medication. The patient's past drug included stone fruit. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Apr2021, about 2 hours after the vaccination, the patient experienced soreness in the right arm (where the shot was given) which continued for another 48 hours. On 29Apr2021 at 09:00, the patient experienced an allergic reaction (non-life threatening) where she had itchy eyes, nose, throat, and neck and her eyes were burning and felt very hot. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with BENADRYL and ALLEGRA. The clinical outcome of the events vaccination site pain, allergic reaction, burning eyes, feeling hot and itchy was resolving. No follow-up attempts are needed. No further information is expected.

On other hand my injection site pain was not as bad as first dose; This is a spontaneous report from a contactable 27-year-old female pharmacist reported for herself that: This is a spontaneous report from a contactable pharmacist reported for herself. A 27-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0171), via an unspecified route of administration, administered in Arm Right on 24Apr2021 17:30 (at the age of 27-year-old) as dose 1, single for covid-19 immunisation. Medical history included polycystic ovaries from an unknown date and unknown if ongoing PCOS, nephrolithiasis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unspecified date in 2021, the patient experienced on other hand my injection site pain was not as bad as first dose. The events were considered as non serious. The outcome of the event was unknown. Follow-up attempts completed. No further information is expected.

7/27/2021 @ 9:00pm broke out in hives, swollen lips & eyes, tight chest, short of breath. Took Benadryl for treatment. 7/28/2021 @ 10:30am broke out in hives. Took Benadryl for treatment. 7/29/2021 @ 03:00am broke out in hives. Took Benadryl. 7/29/2021 @ 12:30pm woke up with palpitations and shaking. No treatment. Called employee health to let them know to document my reactions. I was told by employee health @12:38pm to follow up with my PCP if this continues or worsens.

Minor swollen lymph nodes; A slightly itchy throat; Hives on neck and chest.; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EW0150) via an unspecified route of administration in the left arm on 31Mar2021 at 10:15 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to pollen, latex, dander/dust and smoke. The patient did not receive any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 12:15, the patient experienced minor swollen lymph nodes, a slightly itchy throat and hives on neck and chest. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events minor swollen lymph nodes, a slightly itchy throat and hives on neck and chest was recovered on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.

From 0-24 hours post injection, I had soreness at injection site. At 18 hours post injection, I had abnormal back pain (lasted about 30 minutes). At 29 hours post injection, I had rapid onset chills (lasted 3 hours) and fever (highest measurable was 100.3, lasted about 1 hour), feeling faint (15 minutes), nausea (15 minutes).

tachycardia, nausea, itchiness, tongue swelling (voice change)==> all lasted from 1920pm to 2050pm. Given Benadryl IV and NaCl. Pt in the ER about 2.5 hours.

31Dec 0300 Extreme body ache, unable to move left arm 31Dec Body aches, chills, swelling of injection site 31 Dec 1700 fever 102.1, injection site welt hard, painful, hot with 3 inch diameter, severe body aches and chills. Alternating Tylenol and Motrin begins fever lowers to 99 01Jan severe body aches and chills 01Jan 1130 fever of 101.1 while continuing alternating Tylenol and Motrin administration from previous day. 02Jan no fever, mild body aches, minor swelling and tenderness of injection site.

S: At 1557 patient c/o tongue swelling and itchiness. Given 25mg PO benadryl at 1557   O: Patient alert and oriented, airway patent. BP 129/88 HR 74 O2 98% 1617 Repeat O2 sat 98% HR 59. Patient c/o persistent tongue swelling.   A/P: 28 F with history of nut allergy with tongue swelling after Pfizer vaccine. EMS notified 1620. Patient evaluated by EMS and declined further treatment by EMS and stated that she would walk over to ED for further evaluation.

36 hours after vaccine my face started swelling rapidly. I had extreme swelling and hardening in the areas where I have HA fillers - lips and tear troughs. Both Restylane products. Ended up going to the ER at 2 AM and receiving angioedema/anaphylaxis protocol. IV benedryl, famotidine, and solumedrol. Was put on prednisone and hydroxyzine for at home care for the next 3 days after event. Swelling went down by the next afternoon.

Really strong left arm pain around injection site. Not able to extend or retract my arm for the day after injection. Was really painful, couldn't sleep or apply pressure to arm, also at one point I had an extremely sharp/shooting pain that was in my left arm/neck. Currently 5 months pregnant, due June 7th 2021

She received the vaccine on 12/30/2020 at approximately 4:35 PM. At 7 PM she experienced immediate exhaustion, very hot, and body aches. Her temp when she got home was 102.7. She experienced an all over rash and her temp fluctuated for 65 hours. She went to Urgent Care both on Saturday and Sunday due to the ?burning? of the rash. She received Steroid treatment both days. She is back to work today, however, continues to have burning rash. She was advised by the Urgent Care provider not to receive the second injection, and not to ever receive vaccines with the mRNA component.

Patient reported to me that she developed a rash to her extremities the evening of vaccination. She proceeded to take benadryl. Patient reported taking benadryl repeatedly Tuesday, Wednesday, Thursday, Friday and by Saturday morning she had to go to the ER to get some steroids. Patient stated that it was a hive reaction.

Employee had hives the day following vaccine, went to urgent care received prednisone 50 mg with daily taper, hives have continued to spread daily since. No angioedema or airway issues.

Exactly a week later, I noticed I had a 2 inch lump underneath my chin where my lymph node, it was tender to the touch. on 1/5th, I can still feel the lump, but is not longer tender to the touch. I also developed blisters ( almost like herpes like) on the R side of my nose and on the inside of my nose. I never had blisters in my life, or herpes like blisters on my face. Now on 1/5/21, the blisters are starting to dry, but are still there. I as ask to contact you guys to see if I can get my second dose.